Identity
- Trade Name
- SGR35-3E EUDAMED
- Device Name
- Surgical Gown, Reinforcement EUDAMED
- Model / Reference
- GS1 China EUDAMED
Identifiers
- Primary DI / UDI-DI
- 26972823186286 EUDAMED
- Basic UDI-DI
- 697282318STGOWNRD7 EUDAMED
- EMDN Code
- T020402 REINFORCED SURGICAL GOWNS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Lithuania EUDAMED
Clinical & Handling
Sterile
No
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
Sgr35-3e by Excellent Medical Technology Group 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 | 697282318STGOWNRD7 | Class I | Active |
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Manufacturer
- Manufacturer
- Excellent Medical Technology Group Co., Ltd.
- EUDAMED SRN
- CN-MF-000022462
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 467110d4-fe8f-41ef-a971-7de25b382417 61 fields · synced Jul 9, 2026