Identity
- Trade Name
- Tianbo FDA UDI
- Generic Name
- First aid kit, non-medicated, single-use FDA UDI
- Device Name
- First aid kit EUDAMED
- Model / Reference
- Rule 4 EUDAMEDFA12 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06974712700210 EUDAMED06974712700029 EUDAMED06974712700012 EUDAMEDFDA UDI06974712700104 EUDAMED06974712700722 EUDAMED
- Basic UDI-DI
- 697471270TBJJB1NQ EUDAMED
- FDA Product Code
- OHO FDA UDI
- EMDN Code
- T0203 DRESSING AND ASSISTANCE KITS EUDAMED
- GMDN Term
- First aid kit, non-medicated, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4014 FDA UDI
- Market of Registration
- Northern Ireland EUDAMEDGermany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDEUDAMEDFDA 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
First aid kit by Ningbo Tianbo First Aid Product 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 | 697471270TBJJB1NQ | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Ningbo Tianbo First Aid Product Co., Ltd.
- EUDAMED SRN
- CN-MF-000016721
- Authorised Representative
- Prolinx GmbH DE-AR-000005129
Sources (6)
- EUDAMED 6985980e-e370-482a-b9fe-6d08d8d95bb0 61 fields · synced Jul 24, 2026
- EUDAMED 3ee83bb3-8436-45e3-92dc-bb331ff71135 61 fields · synced May 19, 2026
- EUDAMED 4cc4aa53-cc1d-452b-ac3c-b28356021444 61 fields · synced May 19, 2026
- EUDAMED 305be95a-0b93-4d7b-8ba8-83742d34c5b6 61 fields · synced May 19, 2026
- FDA UDI b6276b36-9fb1-4e16-b967-3af867265862 32 fields · synced May 30, 2026
- EUDAMED 628b6b4b-309f-49e3-843f-dde5b1537f16 61 fields · synced Jul 14, 2026