Identity
- Trade Name
- SG-043-ST-L EUDAMED
- Device Name
- Disposable Surgical Gowns EUDAMED
- Model / Reference
- 354523-CH-S EUDAMEDSG-043-ST-L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08848122000308 EUDAMED
- Basic UDI-DI
- 8848122A001XF EUDAMED
- Direct Marketing DI
- 08848122000308 EUDAMED
- EMDN Code
- T020401 STANDARD SURGICAL GOWNS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Greece 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
Sg-043-St-L by INNOMED Healthcare Products (Cambodia) 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 | 8848122A001XF | Class I | Active |
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Manufacturer
- Manufacturer
- INNOMED Healthcare Products (Cambodia) Co., Ltd.
- EUDAMED SRN
- KH-MF-000030304
- Authorised Representative
- Umedwings Netherlands B.V. NL-AR-000000444
Sources (1)
- EUDAMED 2370e65e-4ae9-4797-bee6-fe78e134407f 61 fields · synced Oct 6, 2026