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urine tube
EUDAMEDClass A (EU MDR)
Ref 13x75mmModel 13x75mm 13x100mm 16x100mm 13x75mm with boric acid 13x100mm with boric acid 16x100mm with boric acid
Identity
- Device Name
- urine tube EUDAMED
- Model / Reference
- 13x75mm 13x100mm 16x100mm 13x75mm with boric acid 13x100mm with boric acid 16x100mm with boric acid EUDAMED13x75mm EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06979377941800 EUDAMED
- Basic UDI-DI
- 697937794UT01YL EUDAMED
- EMDN Code
- W05010202 URINE COLLECTION, TUBES EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
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
No
EUDAMED
New Device
No
EUDAMED
urine tube by Haimen Shengbang Laboratory Equipment Co., 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 | 697937794UT01YL | Class A | Active |
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Manufacturer
- Manufacturer
- Haimen Shengbang Laboratory Equipment Co., Ltd
- EUDAMED SRN
- CN-MF-000009879
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 92ef7755-cba4-44d2-8a18-14602c417334 61 fields · synced Jul 8, 2026