Identity
- Trade Name
- BANDAGE EUDAMEDEMSRUN FDA UDI
- Generic Name
- First aid absorbent pad/bandage FDA UDI
- Device Name
- Bandage EUDAMED
- Model / Reference
- CR-BD01B-1 EUDAMEDCR-BD01J EUDAMEDPZBD0175 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06974567744469 EUDAMEDFDA UDI
- Basic UDI-DI
- 697456774CR-BD01R7 EUDAMED
- FDA Product Code
- FQM FDA UDI
- EMDN Code
- M0304010102 ELASTIC COMPRESSION BANDAGES, NON-ADHESIVE, MEDIUM EXTENSIBILITY (70-140%) 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
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
Yes
FDA UDI
Bandage by Wuxi Emsrun Technology 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 | 697456774CR-BD01R7 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Wuxi Emsrun Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000008968
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED d6f05cb3-fe09-4180-a0df-0c84f273e0d3 61 fields · synced Jul 9, 2026
- FDA UDI 8e003a84-7d4b-4196-8eee-cb066c69ff4a 32 fields · synced May 30, 2026