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COPIOUMED SCRUB SUITS, Blue, Crew-neckline shirt
EUDAMEDFDA UDIClass I (EU MDR)
Ref SSN0B101-1
Identity
- Trade Name
- COPIOUMED SCRUB SUITS, Blue, Crew-neckline shirt EUDAMEDCopioumed FDA UDI
- Generic Name
- Scrub suit, single-use FDA UDI
- Device Name
- SCRUB SUITS and Warm-up JACKET EUDAMEDCopioumed’s scrub suits are protective outfits made for medical personnel for use in operating rooms when they might come in touch with an infectious substance or body fluid. FDA UDI
- Model / Reference
- SSN0B101-1 EUDAMEDFDA UDI
- Description
- Copioumed’s scrub suits are protective outfits made for medical personnel for use in operating rooms when they might come in touch with an infectious substance or body fluid. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04719882250798 EUDAMED04719882250804 FDA UDI
- Basic UDI-DI
- 471988225SS3002HD EUDAMED
- Unit of Use DI
- 04719882250804 EUDAMED
- FDA Product Code
- FXO FDA UDI
- EMDN Code
- T0299 PROTECTION DRAPES AND GARMENTS - OTHER EUDAMED
- GMDN Term
- Scrub suit, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4040 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
COPIOUMED SCRUB SUITS, Blue, Crew-neckline shirt by Copioumed International Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 471988225SS3002HD | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Copioumed International Inc.
- EUDAMED SRN
- TW-MF-000011340
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (2)
- EUDAMED 22c47093-0536-4b17-ba70-eebcbac5286c 61 fields · synced Oct 6, 2026
- FDA UDI f5d81fc9-9d6c-43aa-afc7-56826a9faabf 34 fields · synced May 30, 2026