Identity
- Trade Name
- BANDAGE EUDAMEDEMSRUN FDA UDI
- Generic Name
- Adhesive bandage FDA UDI
- Device Name
- Bandage EUDAMED
- Model / Reference
- CR-BD01B-1 EUDAMEDCR-BD01L-5 EUDAMEDPZBD0154 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06974567741826 EUDAMEDFDA UDI
- Basic UDI-DI
- 697456774CR-BD01R7 EUDAMED
- FDA Product Code
- ITG FDA UDI
- EMDN Code
- M03030202 SKIN PROTECTIVE BANDAGES EUDAMED
- GMDN Term
- Adhesive bandage FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3025 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 50441e31-722c-4194-a789-9efde074d26f 61 fields · synced Jul 17, 2026
- FDA UDI 1d429188-a2d3-490e-a38e-e562dd3768a9 32 fields · synced May 30, 2026