Identity
- Trade Name
- First Aid Kit EUDAMEDOP - First aid series FDA UDI
- Generic Name
- Surgical scrub sponge FDA UDI
- Device Name
- First Aid Kit EUDAMED
- Model / Reference
- 08156 EUDAMEDENFAK20815602 EUDAMEDOP201 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06974686050038 EUDAMEDFDA UDI
- Basic UDI-DI
- 697468605FAK2081563R EUDAMED
- FDA Product Code
- OHO FDA UDI
- EMDN Code
- M9099 GENERAL AND SPECIALIST MEDICAL DEVICES – OTHER (SUTURE PATCHES SEE H900102) EUDAMED
- GMDN Term
- Surgical scrub sponge FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4014 FDA UDI
- Medical Purpose
- Provide first aid EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Ethylene Oxide FDA UDI
First Aid Kit by Yiwu Ori-Power Medtech 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 | 697468605FAK2081563R | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Yiwu Ori-Power Medtech Co., Ltd.
- EUDAMED SRN
- CN-PR-000039035
Sources (2)
- EUDAMED 3562d26d-945b-4d71-a336-1cb64901dbfc 61 fields · synced Oct 6, 2026
- FDA UDI 812397d9-2687-4080-9fe9-d097f7446205 32 fields · synced May 29, 2026