SBS - The best value in QMS software

Where can I find a product's CE Mark Number?

M

MIREGMGR

#11
#11
Sounds exactly like a CE certificate number to me.

Our certificate is numbered "CE XXXXX" where XXXXX is Roman numerals.

Thus there would be one such number for each company that works with an NB that uses such a numbering scheme.

It sounds as if the OP wants to find a list of all CE Marked products of a given type. No such list would exist within the CE Mark system.
 
Quickly Organize an Intelligent TDP from DISCUS
Elsmar Forum Sponsor
J

JB0424

Starting to get Involved
#12
#12
Unfortunately, the product in question has a highlighted section that says "CE XXXXXX" as if the author of the document did not complete that component. Now I am left backtracking to attempt to figure out what the author was trying to convey.
 
M

MIREGMGR

#14
#14
I don't know what the document is that you're referring to. It should be possible though, if you know the company that produced the document, to get a copy of their CE certificate and learn the certificate number.
 
P

pog451

#15
#15
What exactly are you trying to find out?

The CE mark of itself is a self-contained thing - Its presence demonstrates (alleged) conformity. The bad news is that, depending on the exact directive being cited, the CE mark and the label it is on may contain different data. In general a number will refer back to a set of documentation that may contain CoC, a DoP and any other mandated documentation and may or may not refer back to a NoBo. (Without going a looking it up, If I remember rightly a CE mark applied under the CPR and EN1090 would have no reference to a NoBo, you'd have to go back to the manufacturer and their certificate to find out who the NoBo was.

thatz brings us back to - What are you trying to do?
 
P

pog451

#16
#16
MIREGMGR said:
I don't know what the document is that you're referring to. It should be possible though, if you know the company that produced the document, to get a copy of their CE certificate and learn the certificate number.
Click to expand...
Just to be a bit nit-picky here - There is no such thing as a "CE certificate".

Some directives (eg. CPR, PED) allow manufacturers with certain certification (EN1090 FPC and certain PED Modules respectively) to CE-Mark with no further NoBo involvement, but it all depends on the directive and the level of certification.
 
Ronen E

Ronen E

Problem Solver
Staff member
Moderator
#17
#17
pog451 said:
Just to be a bit nit-picky here - There is no such thing as a "CE certificate".

Some directives (eg. CPR, PED) allow manufacturers with certain certification (EN1090 FPC and certain PED Modules respectively) to CE-Mark with no further NoBo involvement, but it all depends on the directive and the level of certification.
Click to expand...
I believe it was just a typo. Perhaps there's no "CE certificate" but there definitely is an "EC certificate" for medical devices.
 
Last edited:
M

MIREGMGR

#18
#18
Yes, sorry.

My employer has an EC certificate numbered "CE XXXXX" where XXXXX is a Roman numeral string, pertaining to certain activities of ours affecting medical device sterilization and sterility maintenance that the issuing Notified Body has determined via investigation and audit supervision to be effective and suitably controlled.

I'm paraphrasing, not having the certificate at this location, but you get the gist.
 
T

ThomasLee

#19
#19
From my understanding anyone who issues a DoC is allowed to give it a number probably for internal tracking/documentation. It is not a legal requirement.
 
M

MIREGMGR

#20
#20
Twice in this thread I said "Roman numerals" when I meant "Arabic numerals".

Yikes. I can tell the difference, honest.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
A Where can we find Statutory and Regulatory Requirements related to our Product? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
D Any recommendations on where to find experienced quality hires in Chicago area? Job Openings, Consulting and Employment Opportunities 3
N Where to find Regulations for Reprocessing and Reuse of Single-Use Devices Other Medical Device Related Standards 2
D Where to find Guidance Class II Amendment Canada Medical Device Regulations 1
M Where can I find examples of PPAP? APQP and PPAP 6
J Where can I find the latest update to Reach and ROHS? REACH and RoHS Conversations 9
G Where to find Proficiency Test provider for photometrics (spectral %R, %T, photo density) General Measurement Device and Calibration Topics 9
M Plating standards - Where to find information AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
D Where I can find an ISO 13485:2016 Audit Schedule example? ISO 13485:2016 - Medical Device Quality Management Systems 4
Proud Liberal DFMEA / PFMEA linkage - Where in the standards do I find it? FMEA and Control Plans 5
N Where I can find an Excel sample/template for recording Delivery Time and Cost Excel .xls Spreadsheet Templates and Tools 2
R Specification on flare testing extruded aluminum - Where to find Design and Development of Products and Processes 1
A AS9100 Rev:D in Spanish - where can I find a Spanish version? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
B Where can I find an English version of Japan's PMD Act? Other ISO and International Standards and European Regulations 2
S Where to Find DEV and DFE numbers on FDA Website Other Medical Device and Orthopedic Related Topics 3
N Where to find a Qualified FDA Supplier Auditor located in China China Medical Device Regulations 7
G Where I could find any project HSE plan templates Occupational Health & Safety Management Standards 4
A Where to find a Draft Copy of IATF 16949:2016? IATF 16949 - Automotive Quality Systems Standard 23
I Where to find VDA 6.3 Robust Production Process (rpp) PDF file ? VDA Standards - Germany's Automotive Standards 1
P Where to find the UMDNS code for CE Mark CE Marking (Conformité Européene) / CB Scheme 1
X Where to find UAE medical device registration regulation and guidelines Other Medical Device Regulations World-Wide 3
P Where to find conformance statistics for ISO 15189 Other Medical Device Regulations World-Wide 1
R Where to find 21 CFR Part 820 Translated into Czech, Spanish, and German 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
A Where can I find the NADCAP Audit Criteria for all the processes? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
L Where to find ISO27000 Annex A? General Auditing Discussions 2
W Where to find the Daimler DBL 6992 10 new (old) standard Customer and Company Specific Requirements 1
V Where I can find an AAR form on Ford Covisint? APQP and PPAP 1
G Where to find the ANSI Z1.9 Rosetta Stone Capability, Accuracy and Stability - Processes, Machines, etc. 9
R How and Where can I find IFU (Instructions For Use) examples? ISO 13485:2016 - Medical Device Quality Management Systems 6
V Where to find Red/White Rust Rating Requirements? APQP and PPAP 4
P VDA 2 - Where to find EMPB (Erstmusterpr?fbericht) bilingual forms VDA Standards - Germany's Automotive Standards 2
K Where do I find Frequencies and Composite Scale in Minitab? Using Minitab Software 2
V Where do I find Adverse Event Database for Medical Devices? Quality Manager and Management Related Issues 2
S Where can I find a (Methods-Time Measurement) MTM-UAS Table? Human Factors and Ergonomics in Engineering 1
V Where to find FORD Specific PPAP Training Training - Internal, External, Online and Distance Learning 3
S Where can I find the World Bank Regulations Texts? Other ISO and International Standards and European Regulations 6
S Where can I find a list of CE Approved Products? CE Marking (Conformité Européene) / CB Scheme 4
J Where to find info about equivalent standards? ESD issues Other ISO and International Standards and European Regulations 4
B Where to find the 510(k) Device Listing Number 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
K ISO Certified, now where to find work? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
Marc Inspectors find safety flaws where airline food is prepared Travel - Hotels, Motels, Planes and Trains 5
J Where to find new GD&T (geometric dimensioning and tolerancing) standards? Various Other Specifications, Standards, and related Requirements 2
Q Where can I find the MDD definition of Labeling? EU Medical Device Regulations 7
O Where to find FAA Part 21 Federal Aviation Administration (FAA) Standards and Requirements 3
G Where to find Ggg-g-17 - Spec is related to GAGE, FILLET AND RADIUS Customer and Company Specific Requirements 7
S Where to find MIL Standard 8A,8B - Used for Dimensioning and Tolerancing Quality Tools, Improvement and Analysis 3
D Where to find Customer Specific Requirements Customer and Company Specific Requirements 6
Q Where to find CFR 820/GMP Training DVDs Book, Video, Blog and Web Site Reviews and Recommendations 7
M Where to find Medical Software Products on the internet? Software Quality Assurance 3
J Bias example-about Df=10.8 - Where to find the df table Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1

Similar threads

Top Bottom