Identity
- Trade Name
- TRAUMA BANDAGE 10cm EUDAMEDTRAUMA BANDAGE FDA UDI
- Generic Name
- First aid absorbent pad/bandage FDA UDI
- Device Name
- TRAUMA BANDAGE EUDAMEDTRAUMA BANDAGE 10 cm FDA UDI
- Model / Reference
- 3207 EUDAMED831273 EUDAMED831273 TRAUMA BANDAGE 10 cm FDA UDI
- Description
- TRAUMA BANDAGE 10 cm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07611600953608 EUDAMEDFDA UDI
- Basic UDI-DI
- 76116003207MC EUDAMED
- FDA Product Code
- MHW FDA UDI
- EMDN Code
- M0304010103 ELASTIC COMPRESSION BANDAGES, NON-ADHESIVE, HIGH EXTENSIBILITY (>140%) 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
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
Yes
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
TRAUMA BANDAGE 10cm by Ivf Hartmann Ag — 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 | 76116003207MC | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ivf Hartmann Ag
- EUDAMED SRN
- CH-MF-000015962
- Authorised Representative
- PAUL HARTMANN AG DE-AR-000007519
Sources (2)
- EUDAMED b56b8e03-99dd-4b19-ae96-50a4471aa5c3 61 fields · synced Oct 6, 2026
- FDA UDI 1d961685-b929-4f41-89ce-ceb7b79d9c21 34 fields · synced May 30, 2026