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Disposable Lab Coat
EUDAMEDFDA UDIClass I (EU MDR)
Ref N/AModel S/M/L/XL/XXL/XXXL/XXXXL
Identity
- Trade Name
- Chongjen FDA UDI
- Generic Name
- Vinyl examination/treatment glove, non-powdered FDA UDI
- Device Name
- Disposable Lab Coat EUDAMED
- Model / Reference
- S/M/L/XL/XXL/XXXL/XXXXL EUDAMEDN/A EUDAMEDDisposable Vinyl Gloves,S FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06974681690079 EUDAMEDFDA UDI
- Basic UDI-DI
- 697468169Lab-Coat9M EUDAMED
- FDA Product Code
- LYU FDA UDI
- EMDN Code
- T0299 PROTECTION DRAPES AND GARMENTS - OTHER EUDAMED
- GMDN Term
- Vinyl examination/treatment glove, non-powdered FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4040 FDA UDI
- Market of Registration
- Belgium 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Disposable Lab Coat by Shanghai chongjen industry 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 | 697468169Lab-Coat9M | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Shanghai chongjen industry co., ltd
- EUDAMED SRN
- CN-MF-000009780
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED 3bdea168-00df-48c9-8983-f4af53dcb0fc 61 fields · synced Jun 18, 2026
- FDA UDI 350b327c-9bce-4cfc-b101-8842913e8f65 32 fields · synced May 30, 2026