Identity
- Trade Name
- Flexiswab™ EUDAMED
- Device Name
- Swab EUDAMED
- Model / Reference
- 0330101 EUDAMED03301 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974345070032 EUDAMED
- Basic UDI-DI
- 6974345070330101MK EUDAMED
- EMDN Code
- A1101 SAMPLE COLLECTION NEUTRAL SWABS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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
Flexiswab™ by Amazing Biotech (Shanghai) 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 | 6974345070330101MK | Class I | Active |
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Manufacturer
- Manufacturer
- Amazing Biotech (Shanghai) Co., LTD
- EUDAMED SRN
- CN-MF-000022383
- Authorised Representative
- Kingsmead Service B.V. NL-AR-000002066
Sources (1)
- EUDAMED 5e6e9822-0739-45ba-97d7-8c86c99442f8 61 fields · synced Jun 18, 2026