Identity
- Trade Name
- bandage EUDAMEDHF FDA UDI
- Generic Name
- Pressure bandage, non-latex, single-use FDA UDI
- Device Name
- Bandage EUDAMED
- Model / Reference
- / EUDAMEDHF A1 EUDAMEDHFEB03 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971519610049 EUDAMEDFDA UDI16971519610954 EUDAMED16971519615492 EUDAMED
- Basic UDI-DI
- 697151961HFEB03EY EUDAMED
- FDA Product Code
- FQM FDA UDI
- EMDN Code
- M0303010103 ELASTIC FIXING BANDAGES, NON-ADHESIVE, EXTENSIBLE IN TWO DIRECTIONS EUDAMEDM03030299 PROTECTION SYSTEMS - OTHER EUDAMED
- GMDN Term
- Pressure bandage, non-latex, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.5075 FDA UDI
- Market of Registration
- Germany EUDAMEDRomania EUDAMED
- 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
Yes
EUDAMEDEUDAMEDFDA 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
Yes
FDA UDI
bandage by Anji Hengfeng Sanitary Material Co., Ltd — 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 | 697151961HFEB03EY | 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 (4)
- EUDAMED c84c724b-ed55-4aa0-add8-e69f53f63db2 61 fields · synced Jul 14, 2026
- FDA UDI d5927587-20d3-4a03-ac3d-cd4252e9a330 32 fields · synced May 30, 2026
- EUDAMED 94106c4d-add7-4a29-8439-e956fed52926 61 fields · synced Jul 10, 2026
- EUDAMED a149e067-18dc-4f5d-8869-4b325a0a3b8f 61 fields · synced Jul 14, 2026