EAC, Simple Code and NACE Code

#1
In our ISO 13485 certificate (we manufacture components for medical devices), it states the following -

EAC - 19
Simple Code - 014
NACE - 33.1

I tried to look into the NACE codes but found that 33.1 is for Repair of fabricated metal products, machinery and equipment

Can somebody give more info on the above codes and confirm if they are correct ?
 
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#3
Not sure which listing you were referring to Ajit but this one looks to cover your scope.

This is a list on the UKAS website but it doesn't have sufficient detail for you
Thanks Colin.

The europa website gives the NACE code for medical devices correctly as 33.1 but when I correspond this to the EAC on the UKAS, the EAC is 19 which happends to be correct but the EA Description reads "Electrical & Optical Equipment" ?
 
D

DRDDO

#4
In our ISO 13485 certificate (we manufacture components for medical devices), it states the following -

EAC - 19
Simple Code - 014
NACE - 33.1

I tried to look into the NACE codes but found that 33.1 is for Repair of fabricated metal products, machinery and equipment

Can somebody give more info on the above codes and confirm if they are correct ?
Hi
NACE Codes related medical devices may be

NACE 17; EAC 4 Textile and Textile Products (for drapes and Gowns)

NACE 27 + 28; EAC 17 Basic Metals and Fabricated Metal Products (for Metallic implants and surgical instruments)

NACE 24.4: EAC 13 Pharmaceuticals (for dressings, wound care products, dental materials and irrigation solutions)

NACE 25; EAC 14 Rubber and Plastic Products (for condoms,gloves, catheters and extruded/moulded devices)

NACE 31.1; EAC 19 Manufacture of Medical Equipment (for most active medical devices)

NACE 51 +52; EAC 29 Wholesale & Retail Trade (excluding food and pharmaceuticals) (for most “own-brand” manufacturers)

NACE 51.46/52.3; EAC 29 Wholesale & Retail of Pharmaceuticals

If your simple code 014 is correct!
I quit sure EAC 19, NACE 31.1 is not correct!!!!!!

Simple code 014 = EAC 14, NACE 25
(NACE 25; EAC 14 Rubber and Plastic Products (for condoms,gloves, catheters and extruded/moulded devices)

:cool:
DRDDO
 
#5
DRDDO,

We have injection plastic molding; so I feel that the below is correct code, right ?

NACE 25; EAC 14 Rubber and Plastic Products (for condoms,gloves, catheters and extruded/moulded devices)

Can you tell me the reference of the above ?

Can you pl explain what is Simple Code and what is the reference of that code ?
 
D

DRDDO

#6
DRDDO,

We have injection plastic molding; so I feel that the below is correct code, right ?

NACE 25; EAC 14 Rubber and Plastic Products (for condoms,gloves, catheters and extruded/moulded devices)

Can you tell me the reference of the above ?

Can you pl explain what is Simple Code and what is the reference of that code ?
Ajit

EAC, NACE is related to ISO 9001 and ISO 13485 too,
Simple code & Complex Code is related CE mark and EU Competent Authority
All is CB concerned = Auditor concerned.
You are Auditee just ask your auditor.
I ask my Auditor: :cool::notme:

Rolland Cook, the 0120 SGS can Answer, I trust
cool:
DRDDO
 
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