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Sample Collection Kit
EUDAMEDClass A (EU MDR)
Ref CWX034H-ONModel CWX033H-O/CWX033H-N/CWX033H-ON/CWX033H-O-P/CWX033H-N-P/CWX033H-ON-P/ CWX034H-O/CWX034H-N/CWX034H-ON/CWX034H-O-P/CWX034H-N-P/CWX034H-ON-P
Identity
- Device Name
- Sample Collection Kit EUDAMED
- Model / Reference
- CWX033H-O/CWX033H-N/CWX033H-ON/CWX033H-O-P/CWX033H-N-P/CWX033H-ON-P/ CWX034H-O/CWX034H-N/CWX034H-ON/CWX034H-O-P/CWX034H-N-P/CWX034H-ON-P EUDAMEDCWX034H-ON EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974454727667 EUDAMED
- Basic UDI-DI
- 697445472V22003X033X0348C EUDAMED
- Direct Marketing DI
- 06974454727667 EUDAMED
- EMDN Code
- A1102 SAMPLE COLLECTION SWABS WITH TRANSPORT MEDIUM EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Spain 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
Sample Collection Kit by Jiangsu CoWin Biotech Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as General-purpose absorbent tip applicator/swab, single-use.
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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 | 697445472V22003X033X0348C | Class A | Active |
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Manufacturer
- Manufacturer
- Jiangsu CoWin Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000008981
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 9eb0f6d8-28aa-4f0d-8418-f6a354a72321 61 fields · synced Jun 18, 2026