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Copioumed Headwear, Blue, Surgical Cap
EUDAMEDFDA UDIClass I (EU MDR)
Ref SCN0B141-1
Identity
- Trade Name
- Copioumed Headwear, Blue, Surgical Cap EUDAMEDCopioumed FDA UDI
- Generic Name
- Surgical cap, single-use FDA UDI
- Device Name
- Headwear EUDAMEDCOPIOUMED Headwear is designed to prevent hair and scalp particles from shedding to protect the patient from the risk of infection. Headwear is also worn by medical personnel in other environments for hygiene reasons. Our wide range of headwear offers different styles, covering requirements for many types of operations and different shapes and sizes of heads and hairstyles. Single-use and non-sterile. FDA UDI
- Model / Reference
- SCN0B141-1 EUDAMEDFDA UDI
- Description
- COPIOUMED Headwear is designed to prevent hair and scalp particles from shedding to protect the patient from the risk of infection. Headwear is also worn by medical personnel in other environments for hygiene reasons. Our wide range of headwear offers different styles, covering requirements for many types of operations and different shapes and sizes of heads and hairstyles. Single-use and non-sterile. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04719882252693 EUDAMED04719882252709 FDA UDI
- Basic UDI-DI
- 471988225SC3004BZ EUDAMED
- Unit of Use DI
- 04719882252709 EUDAMED
- FDA Product Code
- FYF FDA UDI
- EMDN Code
- T0207 CAPS AND HEADWEAR (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE) EUDAMED
- GMDN Term
- Surgical cap, 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 Headwear, Blue, Surgical Cap by Copioumed International Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 471988225SC3004BZ | 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 29317352-022a-4a05-a273-d72b15911332 61 fields · synced Jun 19, 2026
- FDA UDI 69922d9b-8b02-4a98-9a3a-a6dbe2b93f2b 34 fields · synced May 29, 2026