Identity
- Trade Name
- Flexiswab™ EUDAMED
- Device Name
- Swab EUDAMED
- Model / Reference
- 0020101 EUDAMED0020104 EUDAMED0020102 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975181140002 EUDAMED06975181140071 EUDAMED06975181140057 EUDAMED
- Basic UDI-DI
- 6975181140020101J6 EUDAMED6975181140020104JC EUDAMED6975181140020102J8 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
Category: General-purpose absorbent tip applicator/swab, single-use
Flexiswab™ by Hopfly Biotech (Huzhou) CO., LTD — Class I — MDR — 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/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 6975181140020101J6 | Class I | Active |
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Manufacturer
- Manufacturer
- Hopfly Biotech (Huzhou) CO., LTD
- EUDAMED SRN
- CN-MF-000022345
- Authorised Representative
- Kingsmead Service B.V. NL-AR-000002066
Sources (3)
- EUDAMED 0d207c18-d57f-4d33-b5c4-7ef745735506 61 fields · synced Jul 24, 2026
- EUDAMED 618c76b4-e3c2-4477-b4ba-1502fbe02ed1 61 fields · synced May 17, 2026
- EUDAMED 1319fc94-3077-4548-9086-d1c7bebace34 61 fields · synced May 18, 2026