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Specimen Collection Flocked Swab
EUDAMEDClass I (EU MDR)
Ref 18-07-0065Model Nasopharyngeal swab-A,B,C,Oropharyngeal swab-A,B,C
Identity
- Trade Name
- Specimen Collection Flocked Swab EUDAMED
- Device Name
- Specimen Collection Flocked Swab (non-sterile) EUDAMED
- Model / Reference
- Nasopharyngeal swab-A,B,C,Oropharyngeal swab-A,B,C EUDAMED18-07-0065 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974674893746 EUDAMED
- Basic UDI-DI
- 697467489swab022M EUDAMED
- EMDN Code
- A1101 SAMPLE COLLECTION NEUTRAL SWABS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Specimen Collection Flocked Swab by Shenzhen Zijian Biotechnology Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697467489swab022M | Class I | Active |
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Manufacturer
- Manufacturer
- Shenzhen Zijian Biotechnology Co., Ltd
- EUDAMED SRN
- CN-MF-000022829
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED bfa2dbc4-e06b-424b-8a18-dd76c7a1365f 61 fields · synced Jun 18, 2026