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Urine Sample Preservation Solution
EUDAMEDClass A (EU MDR)
Ref HBPM/UModel 1.5 mL/Tube, 25 tubes/box; 3.0 mL/Tube, 25 tubes/box; 0.8 mL/Tube, 48 tubes/box
Identity
- Device Name
- Urine Sample Preservation Solution EUDAMED
- Model / Reference
- 1.5 mL/Tube, 25 tubes/box; 3.0 mL/Tube, 25 tubes/box; 0.8 mL/Tube, 48 tubes/box EUDAMEDHBPM/U EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942221703213 EUDAMED
- Basic UDI-DI
- 69422217HBPMUN8 EUDAMED
- EMDN Code
- W05010299 URINE COLLECTION DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Urine Sample Preservation Solution by Chaozhou Hybribio Biochemistry Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 69422217HBPMUN8 | Class A | Active |
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Manufacturer
- Manufacturer
- Chaozhou Hybribio Biochemistry Ltd.
- EUDAMED SRN
- CN-MF-000023818
- Authorised Representative
- Kingsmead Service B.V. NL-AR-000002066
Sources (1)
- EUDAMED 2178f536-5e79-4ea3-8e0f-d57e1b388570 61 fields · synced Jul 9, 2026