X-ray detectable cotton threads

An old classmate asked me for a help. His company produces this product- X-ray detectable thread. It seems that they translated this name in a very Chinese way.

Few people can speak English in the company. But they are in urgent need to find a business partner - a certification company in Germany, or an organization which can prove their products to be qualified to a certian criteria. They are dealing with this matter for the first time.

Any nice TTer has ever heard about this product? What kind of certifications are usually needed? Sorry for such little infomation. It would be very nice of you if you could tell me about some basics about the product and its certification procedures. Ashamed that I know nothing about pharmacy.

I'll be offline for a while today. Many thanks in advance.

Since I'm killing a day doing installations and waiting a lot I had time to search for the relevant certifications. X-ray-detectable cotton (or "radiopaque") is normally used in medical dressings. The detectable thread makes it easy to check for forgotten pieces of gauze after surgery. The main certifications are:
ISO 9000
ISO 9001
ISO 13485
EN 46001

I think CE approval comes under Directive 93/42/EEC (at least for guaze) but I have no idea what the relevant FDA process is. They'll need to find that out.

woof.

Any medical experts here? A friend of mine needs to get the following certificates for exportation use. His company produces X-ray detectable cotton thread.

Cytotoxicity Test
Delayed Contact Sensitization Study (A Maximization Method In the Guinea Pig) (ISO 10993)
Skin Irritation Test (ISO 10993)
Hemolysis Test (ISO 10993)
Tensile Strength (ISO 11607)

I checked TÜV Munich webpages and found that this org could make such certifications. There are two types of medical use products - Active and Non-active. My question is what's the difference between them? Does X-Ray detectable cotton thread belong to the Active products?

Link: http://www.tuev-sued.de/product_services/m...edical_products

Many thanks in advance.

After searching for one day and a half, I found some useful infos. Maybe they would be useful for some folks here.

http://www.zlg.de/cms.php?PHPSESSID=2a0a61...3&mapid=1&hmp=0

For Asian markets,
http://www.gfps.de/deutsch/start.html

People there work on ISO and CE certificates. Very glad to find something useful for my classmate.