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Disposable Virus Sampling Swab Kits
EUDAMEDClass A (EU MDR)
Ref ZK1500-2Model ZK1000-1, ZK1500-1, ZK1000-5, ZK1500-2, ZK1500-3, ZK1500-4, ZK1500-5
Identity
- Device Name
- Disposable Virus Sampling Swab Kits EUDAMED
- Model / Reference
- ZK1000-1, ZK1500-1, ZK1000-5, ZK1500-2, ZK1500-3, ZK1500-4, ZK1500-5 EUDAMEDZK1500-2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974541563420 EUDAMED
- Basic UDI-DI
- 697454156008L9 EUDAMED
- EMDN Code
- W0105900103 SUPPLEMENTAL NA REAGENTS 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
Yes
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
EUDAMED
Disposable Virus Sampling Swab Kits by Bioteke Corporation (Wuxi) 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 | 697454156008L9 | Class A | Active |
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Manufacturer
- Manufacturer
- BioTeke Corporation（Wuxi）Co., Ltd
- EUDAMED SRN
- CN-MF-000007517
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 6263a0e2-e50b-40ad-bf4c-3395ff2e61e2 61 fields · synced Jun 18, 2026