Identity
- Trade Name
- Disposable Virus Sampling Collector EUDAMED
- Device Name
- Disposable Virus Sampling Collector EUDAMED
- Model / Reference
- KY001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973131520669 EUDAMED
- Basic UDI-DI
- 697313152KY001C5 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 Collector by Biobase Scientific (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 | 697313152KY001C5 | Class A | Active |
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Manufacturer
- Manufacturer
- Biobase Scientific (Shandong) Co., Ltd
- EUDAMED SRN
- CN-MF-000011660
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED a494aa1b-e5e3-4029-8719-5d7d4daea35b 61 fields · synced Jun 19, 2026