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Isolation Gown
EUDAMEDClass I (EU MDR)
Ref MC121AModel MC121a MC121b reverse wear style MC122a MC122b MC123 suit style MC124a MC124b MC124c MC124d MC124e MC124f coverall style MC125a MC125b MC125c MC125d obverse wear style M/L/XL/XXL
Identity
- Device Name
- Isolation Gown EUDAMED
- Model / Reference
- MC121a MC121b reverse wear style MC122a MC122b MC123 suit style MC124a MC124b MC124c MC124d MC124e MC124f coverall style MC125a MC125b MC125c MC125d obverse wear style M/L/XL/XXL EUDAMEDMC121A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975883470773 EUDAMED
- Basic UDI-DI
- 697588347IsolationGown3A EUDAMED
- EMDN Code
- T0299 PROTECTION DRAPES AND GARMENTS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Isolation Gown by Hospital & Homecare Medical Device Co., Ltd. China — 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 | 697588347IsolationGown3A | Class I | Active |
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Manufacturer
- Manufacturer
- Hospital & Homecare Medical Device Co., Ltd. China
- EUDAMED SRN
- CN-MF-000032014
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 4bc5b803-df08-4451-992e-fed1f30dd25c 61 fields · synced Oct 6, 2026