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Adhesive bandage
EUDAMEDFDA UDIClass I (EU MDR)
Ref CR-AB01-5Model CR-AB01,CR-AB02
Identity
- Trade Name
- Adhesive bandage EUDAMEDEMSRUN FDA UDI
- Generic Name
- Adhesive bandage FDA UDI
- Device Name
- ADHESIVE BANDAGE EUDAMED
- Model / Reference
- CR-AB01,CR-AB02 EUDAMEDCR-AB01-5 EUDAMEDPZZN0006 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06974567741642 EUDAMEDFDA UDI
- Basic UDI-DI
- 697456774CR-AB01QN EUDAMED
- FDA Product Code
- ITG FDA UDI
- EMDN Code
- M0303010203 ELASTIC FIXING BANDAGES, SELF-ADHESIVE, EXTENSIBLE IN TWO DIRECTIONS 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
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 0f9a6f52-98f9-4294-ab5c-9e0cfd0495ad 61 fields · synced Jun 19, 2026
- FDA UDI 66dcdeac-9fbb-404e-9ed1-d998e43fd2ab 32 fields · synced May 29, 2026