Identity
- Trade Name
- N/A FDA UDI
- Generic Name
- General-purpose centrifuge IVD FDA UDI
- Device Name
- Vacuum tube EUDAMEDSeparation of liquid in test tube by centrifugal force rotation FDA UDI
- Model / Reference
- 15ml EUDAMED004 EUDAMEDTD5 FDA UDI
- Description
- Separation of liquid in test tube by centrifugal force rotation FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06974594960047 EUDAMEDFDA UDI
- Basic UDI-DI
- 69745949615mlRW EUDAMED
- Direct Marketing DI
- 06974594960047 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
Vacuum tube 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 | 69745949615mlRW | 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 d11d276d-5697-4528-bcdd-e1c9dc9e6a11 61 fields · synced Jun 18, 2026
- FDA UDI e7c88764-6fd6-4f4e-af41-d16035f87f4d 33 fields · synced May 30, 2026