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Sterile dressing combine（GAMMA）
EUDAMEDClass I (EU MDR)
Ref 09-890PModel 10 x 10 cm, 10 x 20 cm, 15 x 20 cm, 20 x 20 cm, 20 x 40 cm.Ref 09-892PRef 09-891P
Identity
- Trade Name
- Sterile dressing combine（GAMMA） EUDAMED
- Model / Reference
- 10 x 10 cm, 10 x 20 cm, 15 x 20 cm, 20 x 20 cm, 20 x 40 cm. EUDAMED09-890P EUDAMED09-892P EUDAMED09-891P EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972013960043 EUDAMED06972013960845 EUDAMED06972013960838 EUDAMED
- Basic UDI-DI
- 697201396MU01SNNNSDC001ZK EUDAMED
- Direct Marketing DI
- 06972013960043 EUDAMED06972013960845 EUDAMED06972013960838 EUDAMED
- EMDN Code
- M040201 ABSORBENT DRESSINGS WITH CELLULOSE PAD AND NON-WOVEN WRAPS 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 dressing combine（GAMMA） 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 | 697201396MU01SNNNSDC001ZK | 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 (3)
- EUDAMED d559a70c-c03d-4b13-b621-b079d1e8a3ee 61 fields · synced Jul 20, 2026
- EUDAMED 4b9a262b-f24d-4b6f-9992-a9df2f0ad839 61 fields · synced May 18, 2026
- EUDAMED cfe2a082-05c8-4755-aa2e-d5dbaa689c0a 61 fields · synced May 18, 2026