Identity
- Trade Name
- First Aid Kit EUDAMEDEMSRUN FDA UDI
- Generic Name
- First aid kit, non-medicated, reusable FDA UDI
- Device Name
- Firsr Aid Kit EUDAMED
- Model / Reference
- CR-Q1 EUDAMEDCR-QB006A EUDAMEDHWMY0001 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06974567743028 EUDAMEDFDA UDI
- Basic UDI-DI
- 697456774CR-QB001AFS EUDAMED
- FDA Product Code
- OHO FDA UDI
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER 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
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Device sterilization/disinfection container, reusable
First Aid Kit by Wuxi Emsrun Technology Co., Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697456774CR-QB001AFS | 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 6f9d572f-b05b-4ef5-be4b-c931f2c53895 61 fields · synced Jun 18, 2026
- FDA UDI 5befe18f-977f-4ac4-8a35-29f0d7057320 32 fields · synced May 30, 2026