← Back to catalogue
Disposable Surgical Gowns
EUDAMEDClass I (EU MDR)
Ref 354533-CH-SModel 354523-CH-SRef SG-043-PR-L
Identity
- Trade Name
- Disposable Surgical Gowns EUDAMED
- Device Name
- Disposable Surgical Gowns EUDAMED
- Model / Reference
- 354523-CH-S EUDAMED354533-CH-S EUDAMEDSG-043-PR-L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08848122000087 EUDAMED08848122000292 EUDAMED
- Basic UDI-DI
- 8848122A001XF EUDAMED8848122A009XX EUDAMED
- Direct Marketing DI
- 08848122000087 EUDAMED08848122000292 EUDAMED
- EMDN Code
- T020401 STANDARD SURGICAL GOWNS EUDAMEDT020402 REINFORCED SURGICAL GOWNS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Czechia EUDAMEDGreece 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
Disposable Surgical Gowns 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- INNOMED Healthcare Products (Cambodia) Co., Ltd.
- EUDAMED SRN
- KH-MF-000030304
- Authorised Representative
- Umedwings Netherlands B.V. NL-AR-000000444
Sources (2)
- EUDAMED fff4d937-f6df-497d-96c7-6cd94d0a782e 61 fields · synced Oct 7, 2026
- EUDAMED 67a0b228-ffa7-4c20-a457-091cc6e5a2aa 61 fields · synced May 18, 2026