Identity
- Device Name
- Surgical Gowns EUDAMED
- Model / Reference
- 97-8000-S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16931918145785 EUDAMED
- Basic UDI-DI
- 69319181F002KM EUDAMED
- EMDN Code
- T020401 STANDARD SURGICAL GOWNS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
Surgical Gowns by GRI Medical & Electronic Technology 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 | 69319181F002KM | Class I | Active |
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Manufacturer
- Manufacturer
- GRI Medical & Electronic Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000004203
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED cf5b70e5-b427-4bee-96f5-952f7b2fefd2 61 fields · synced Sep 18, 2026