Identity
- Trade Name
- EMERGENCY BANDAGE EUDAMEDHF FDA UDI
- Generic Name
- First aid absorbent pad/bandage FDA UDI
- Device Name
- Sterile First Aid Bandage EUDAMED
- Model / Reference
- HFFAB1 EUDAMEDHFFAB1-2 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971519616584 EUDAMEDFDA UDI
- Basic UDI-DI
- 697151961HFFAB1GH EUDAMED
- FDA Product Code
- FQM FDA UDI
- EMDN Code
- M03030299 PROTECTION SYSTEMS - OTHER EUDAMED
- GMDN Term
- First aid absorbent pad/bandage FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.5075 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
Yes
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Cast/bandage waterproof bathing cover, reusable
Emergency Bandage by Anji Hengfeng Sanitary Material Co., Ltd — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697151961HFFAB1GH | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Anji Hengfeng Sanitary Material Co., Ltd
- EUDAMED SRN
- CN-MF-000013051
- Authorised Representative
- Caretechion GmbH DE-AR-000005946
Sources (2)
- EUDAMED 270bb2f2-0dc0-4b6f-b24d-cde943bc897f 61 fields · synced Jul 8, 2026
- FDA UDI e1cf5a5f-bb6a-4d1d-8278-3c3a10980d8c 32 fields · synced May 30, 2026