Identity
- Trade Name
- TRAUMA BANDAGE 15cm EUDAMEDTRAUMA BANDAGE FDA UDI
- Generic Name
- First aid absorbent pad/bandage FDA UDI
- Device Name
- TRAUMA BANDAGE EUDAMEDTRAUMA BANDAGE 15 cm FDA UDI
- Model / Reference
- 3207 EUDAMED831274 EUDAMED831274 TRAUMA BANDAGE 15 cm FDA UDI
- Description
- TRAUMA BANDAGE 15 cm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07611600953684 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 15cm 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 |
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Manufacturer
- Manufacturer
- Ivf Hartmann Ag
- EUDAMED SRN
- CH-MF-000015962
- Authorised Representative
- PAUL HARTMANN AG DE-AR-000007519
Sources (2)
- EUDAMED cb6826a2-56df-43ab-a93f-d33f740d8efc 61 fields · synced Oct 6, 2026
- FDA UDI 9c5a3ca0-e519-4a09-a2d4-41ead3560a3a 34 fields · synced May 30, 2026