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Sterile gauze swabs / balls
EUDAMEDClass I (EU MDR)
Ref 15-009Model (2.5-15cm)x(5-45cm)- 4/6/8/9/12/15/16/24/32/48/64ply Rectangular shape: 1~20 cm×2 ~100 cm- 1~64 ply Ball-shaped: ф 2.5 cm, ф 3 cm, ф 4 cm, ф 5 cmRef 15-007Ref 15-008Ref 15-003Ref 15-006Ref 15-005
Identity
- Trade Name
- Sterile gauze swabs / balls EUDAMED
- Device Name
- Sterile gauze swabs / balls EUDAMED
- Model / Reference
- (2.5-15cm)x(5-45cm)- 4/6/8/9/12/15/16/24/32/48/64ply Rectangular shape: 1~20 cm×2 ~100 cm- 1~64 ply Ball-shaped: ф 2.5 cm, ф 3 cm, ф 4 cm, ф 5 cm EUDAMED15-009 EUDAMED15-007 EUDAMED15-008 EUDAMED15-003 EUDAMED15-006 EUDAMED15-005 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972013960975 EUDAMED06972013960944 EUDAMED06972013960968 EUDAMED06972013960982 EUDAMED06972013960951 EUDAMED06972013961002 EUDAMED
- Basic UDI-DI
- 697201396MU01SNNNSGS00167 EUDAMED
- Direct Marketing DI
- 06972013960975 EUDAMED06972013960944 EUDAMED06972013960968 EUDAMED06972013960982 EUDAMED06972013960951 EUDAMED06972013961002 EUDAMED
- EMDN Code
- M0201020101 COTTON GAUZES, FOLDED, 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 gauze swabs / balls 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 | 697201396MU01SNNNSGS00167 | 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 (12)
- EUDAMED 71b1f4ca-16b5-4ff0-81fe-4f34e83517ce 61 fields · synced Sep 17, 2026
- EUDAMED acfa2c74-1321-4eea-9209-5d34f5207184 61 fields · synced May 17, 2026
- EUDAMED ffb10c0f-066c-4c88-b499-3a5e6e90fa14 61 fields · synced May 17, 2026
- EUDAMED ae4734df-710c-41f4-9606-1a51a6e5a3c5 61 fields · synced May 18, 2026
- EUDAMED 7b87182c-487c-4fbd-b53e-2223c11c2929 61 fields · synced May 19, 2026
- EUDAMED e8c1caa3-4d9e-4a30-b6bc-c46d82581ba2 61 fields · synced May 19, 2026
- EUDAMED 30df06ef-a87f-45a5-b491-1b1c6f1e72a9 61 fields · synced Jul 9, 2026
- EUDAMED 34b1464b-c907-4857-87f8-c642af76e78c 61 fields · synced Jul 10, 2026
- EUDAMED 723af1f3-ce90-4245-96b1-54183942cdc5 61 fields · synced Jul 11, 2026
- EUDAMED 61989e2f-3c9d-40c6-ad33-2f46b8e20c0f 61 fields · synced Jul 30, 2026
- EUDAMED b0a21243-8b08-4c00-9222-32023c20996b 61 fields · synced Aug 4, 2026
- EUDAMED 5fdc7b22-1c3f-489f-ab8d-c61b828f9b48 61 fields · synced Sep 17, 2026