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Sterile Surgical Gown
EUDAMEDClass I (EU MDR)
Ref 28-048Model XS S M L XL XXLRef 28-044Model XS/S/M/L/XL/XXL
Identity
- Trade Name
- Sterile Surgical Gown EUDAMED
- Device Name
- Sterile Surgical Gown EUDAMED
- Model / Reference
- XS S M L XL XXL EUDAMED28-048 EUDAMEDXS/S/M/L/XL/XXL EUDAMED28-044 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972013961446 EUDAMED06972013961217 EUDAMED
- Basic UDI-DI
- 697201396MU01SNNNSSG0027R EUDAMED697201396MU01SNNNSSG0017P EUDAMED
- Direct Marketing DI
- 06972013961446 EUDAMED06972013961217 EUDAMED
- EMDN Code
- T020402 REINFORCED SURGICAL GOWNS EUDAMEDT020401 STANDARD SURGICAL GOWNS 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 Surgical Gown 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 | 697201396MU01SNNNSSG0027R | 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 (4)
- EUDAMED 7f6eb9ec-b10b-422c-a66b-ca9b751d1c4c 61 fields · synced Jul 17, 2026
- EUDAMED e9eafd94-e76d-4030-acb3-c1e53baa88d2 61 fields · synced May 19, 2026
- EUDAMED 9af8662f-9973-44b9-a5a5-e57f9c4c30a4 61 fields · synced Jul 14, 2026
- EUDAMED 5406a1b7-a349-4de4-bacf-99e18fc391d6 61 fields · synced Jul 17, 2026