Identity
- Trade Name
- N/A FDA UDI
- Generic Name
- General-purpose centrifuge IVD FDA UDI
- Device Name
- Separation of liquid in test tube by centrifugal force rotation FDA UDI
- Model / Reference
- 10ml EUDAMEDTD4B FDA UDI
- Description
- Separation of liquid in test tube by centrifugal force rotation FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06974594960023 EUDAMEDFDA UDI
- Basic UDI-DI
- 69745949610mlR5 EUDAMED
- Direct Marketing DI
- 06974594960023 EUDAMED
- FDA Product Code
- JQC FDA UDI
- EMDN Code
- W05019099 SAMPLES COLLECTION DEVICES - OTHER EUDAMED
- GMDN Term
- General-purpose centrifuge IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 862.2050 FDA UDI
- Market of Registration
- Romania EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
No
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
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
Yes
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
10ml by Hbh Biotechnology Limited — 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 | 69745949610mlR5 | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Hbh Biotechnology Limited
- EUDAMED SRN
- CN-MF-000033712
- Authorised Representative
- Kingsmead Service B.V. NL-AR-000002066
Sources (2)
- EUDAMED d213743e-88e2-4dbb-b362-4d3f1fdedda6 61 fields · synced Jul 30, 2026
- FDA UDI 5d7f2e42-bf20-4ef6-b246-173c6b132f05 33 fields · synced May 30, 2026