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Vacuum tube
EUDAMEDFDA UDIClass A (EU MDR)
Ref 001Model 7mlRef 006Model 30mlRef 007Model 40mlRef 005Model 20ml
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
- 7ml EUDAMED001 EUDAMED30ml EUDAMED006 EUDAMED40ml EUDAMED007 EUDAMED20ml EUDAMED005 EUDAMEDTD4C FDA UDI
- Description
- Separation of liquid in test tube by centrifugal force rotation FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06974594960016 EUDAMEDFDA UDI06974594960061 EUDAMED06974594960078 EUDAMED06974594960054 EUDAMED
- Basic UDI-DI
- 6974594967ml2Q EUDAMED69745949630mlRK EUDAMED69745949640mlRS EUDAMED69745949620mlRC EUDAMED
- Direct Marketing DI
- 06974594960016 EUDAMED06974594960061 EUDAMED06974594960078 EUDAMED06974594960054 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
No
EUDAMEDEUDAMED
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 | 6974594967ml2Q | 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 (5)
- EUDAMED ecae0aa5-9f48-42a5-a32d-cc48304b7b4a 61 fields · synced Jul 18, 2026
- EUDAMED e0ca3924-67f2-411a-b697-e19eb970c398 61 fields · synced May 17, 2026
- EUDAMED cd6d728a-68f8-40d0-89d6-24cc95d7c902 61 fields · synced May 19, 2026
- EUDAMED 8f496b2c-ec8a-4391-87c5-f30955bf2259 61 fields · synced May 19, 2026
- FDA UDI 02f35c18-c503-4d05-ba1d-cdf6d9c4d29d 33 fields · synced May 30, 2026