Identity
- Trade Name
- Reaction vessel FDA UDI
- Generic Name
- Laboratory analyser cuvette IVD, single-use FDA UDI
- Device Name
- Reaction vessel EUDAMED2000 pcs/box (2 bag/box, 1000 pcs/bag) FDA UDI
- Model / Reference
- C6100 EUDAMEDFDA UDI
- Description
- 2000 pcs/box (2 bag/box, 1000 pcs/bag) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06925912708513 EUDAMEDFDA UDI
- Basic UDI-DI
- 692591270147HG EUDAMED
- FDA Product Code
- JRI FDA UDI
- EMDN Code
- W0503010203 SAMPLES ANALYSES, PLASTIC CUVETTES EUDAMED
- GMDN Term
- Laboratory analyser cuvette IVD, single-use FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 862.2050 FDA UDI
- Market of Registration
- France 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
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
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
Reaction vessel by Shenzhen Yhlo Biotech Co., Ltd. — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 692591270147HG | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shenzhen Yhlo Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000001137
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 8b8f99b0-d8d1-4b95-9b1d-401c39384980 61 fields · synced Jun 18, 2026
- FDA UDI 17bbf3b8-67ff-4b31-a764-67484ca71604 33 fields · synced May 30, 2026