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Sterile Non-woven Swabs
EUDAMEDClass I (EU MDR)
Ref 67- 338DModel Rectangular shape:5cmx5cm、7.5cmx7.5cm、10cmx10cm , Ball-shaped: ф 2.5 cm, ф 3 cm, ф 4 cm, ф 5 cm
Identity
- Trade Name
- Sterile Non-woven Swabs EUDAMED
- Device Name
- Sterile Non-woven Swabs EUDAMED
- Model / Reference
- Rectangular shape:5cmx5cm、7.5cmx7.5cm、10cmx10cm , Ball-shaped: ф 2.5 cm, ф 3 cm, ф 4 cm, ф 5 cm EUDAMED67- 338D EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972013960937 EUDAMED
- Basic UDI-DI
- 697201396MU01SNNNSNS0018L EUDAMED
- Direct Marketing DI
- 06972013960937 EUDAMED
- EMDN Code
- M0202010101 NON-WOVEN FOLDED GAUZES, WITHOUT X-RAY DETECTABLE THREAD, STERILE EUDAMED
Classification
- Device Class
- Class I EUDAMED
Clinical & Handling
Sterile
Yes
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
Sterile Non-woven Swabs by Multigate 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 | 697201396MU01SNNNSNS0018L | Class I | Active |
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Manufacturer
- Manufacturer
- Multigate Co., Ltd
- EUDAMED SRN
- CN-MF-000002513
- Authorised Representative
- RFX+Care International A/S DK-AR-000001768
Sources (2)
- EUDAMED 7f27e8c4-2277-4446-a96a-ca9de1d79512 61 fields · synced Jun 19, 2026
- EUDAMED 1f27ebc1-8fc1-42e0-b63f-ee52a93ccc7b 61 fields · synced Jun 19, 2026