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Disposable Virus Sampling Tube
EUDAMEDClass A (EU MDR)
Ref 3980222Model FB, FY, MB. MY, FBY, MBY, DEB, DEY
Identity
- Device Name
- Disposable Virus Sampling Tube EUDAMED
- Model / Reference
- FB, FY, MB. MY, FBY, MBY, DEB, DEY EUDAMED3980222 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973471960057 EUDAMED
- Basic UDI-DI
- 697347196398DVSBA EUDAMED
- EMDN Code
- A1102 SAMPLE COLLECTION SWABS WITH TRANSPORT MEDIUM 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
Category: General-purpose absorbent tip applicator/swab, single-use
Disposable Virus Sampling Tube by Shenzhen Dakewe Bio-Engineering Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as General-purpose absorbent tip applicator/swab, single-use.
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- Microbrush — YOUNG MICROBRUSH LLC · Class I
- CITOTEST — CITOTEST LABWARE MANUFACTURING CO.,LTD · Class I
- ESCOB.FLOCK NASOF. 80MM FLOW — Deltalab, S.L. · Class I
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 | 697347196398DVSBA | Class A | Active |
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Manufacturer
- Manufacturer
- Shenzhen Dakewe Bio-engineering Co., Ltd.
- EUDAMED SRN
- CN-MF-000002174
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED aac721ba-2277-4450-8666-2bbb32073506 61 fields · synced Jun 18, 2026