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Adhesive Bandage
EUDAMEDFDA UDIClass I (EU MDR)
Ref CR-AB01-16Model CR-AB01,CR-AB02
Identity
- Trade Name
- Adhesive Bandage EUDAMEDRHINO RESCUE FDA UDI
- Generic Name
- First aid kit, non-medicated, reusable FDA UDI
- Device Name
- ADHESIVE BANDAGE EUDAMED
- Model / Reference
- CR-AB01,CR-AB02 EUDAMEDCR-AB01-16 EUDAMEDCPIK0096 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06974567745824 EUDAMEDFDA UDI
- Basic UDI-DI
- 697456774CR-AB01QN EUDAMED
- FDA Product Code
- OHO FDA UDI
- EMDN Code
- M03030202 SKIN PROTECTIVE BANDAGES EUDAMED
- GMDN Term
- First aid kit, non-medicated, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4014 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Adhesive 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-AB01QN | 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 fae17061-ec4d-464f-8970-9942abd1ee3d 61 fields · synced Jun 19, 2026
- FDA UDI 8a2ab328-2b27-4c62-aad9-4f20af503340 32 fields · synced May 25, 2026