Identity
- Trade Name
- Disposable Virus Sampling Tube EUDAMED
- Device Name
- Disposable Virus Sampling Tube EUDAMED
- Model / Reference
- ZD004 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974969980885 EUDAMED06974969980878 EUDAMED06974969980939 EUDAMED06974969980922 EUDAMED06974969980892 EUDAMED06974969980847 EUDAMED06974969980915 EUDAMED
- Basic UDI-DI
- 697496998ZD004YK EUDAMED
- EMDN Code
- W05019099 SAMPLES COLLECTION DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany 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
Disposable Virus Sampling Tube by Biobase Diagnostic Technology (Shandong) 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 | 697496998ZD004YK | Class A | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biobase Diagnostic Technology (Shandong) Co., Ltd.
- EUDAMED SRN
- CN-MF-000025964
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (7)
- EUDAMED 52e65aed-b8ef-4236-87ac-2a80ec0cbe18 61 fields · synced Oct 5, 2026
- EUDAMED 3261c27c-caae-4502-808e-9dd2f454c2e0 61 fields · synced May 17, 2026
- EUDAMED 4f5f4012-d7de-41b5-a06d-b652c260629e 61 fields · synced May 18, 2026
- EUDAMED 2105e3ae-f63a-41e1-ada5-3f94baa3ceb4 61 fields · synced May 19, 2026
- EUDAMED ccf4e5dc-d944-450f-901c-b0b5b9784151 61 fields · synced May 19, 2026
- EUDAMED 603f1414-81ea-4c7d-a15d-a7ab6f5f2307 61 fields · synced May 19, 2026
- EUDAMED 22ae9b3a-84e8-4f70-a5c1-c394de333c15 61 fields · synced May 19, 2026