Identity
- Trade Name
- Sterile Surgical Gown EUDAMED
- Device Name
- Sterile Surgical Gown EUDAMED
- Model / Reference
- XS S M L XL XXL EUDAMED28-046 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972013961422 EUDAMED
- Basic UDI-DI
- 697201396MU01SNNNSSG0027R EUDAMED
- Direct Marketing DI
- 06972013961422 EUDAMED
- EMDN Code
- T020402 REINFORCED 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 (2)
- EUDAMED 92ef6161-d292-4293-a909-78cbce2af480 61 fields · synced Jun 19, 2026
- EUDAMED e14f07b0-7cac-4cf0-ac59-91701d251e57 61 fields · synced Jun 19, 2026