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Isolation Gown XL
EUDAMEDClass I (EU MDR)
Ref HY1-50044Model Isolation and Surgical gowns
by Hygitech
Identity
- Trade Name
- Isolation Gown XL EUDAMED
- Device Name
- Isolation and Surgical gowns EUDAMED
- Model / Reference
- Isolation and Surgical gowns EUDAMEDHY1-50044 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03615140006606 EUDAMED
- Basic UDI-DI
- 361514H2PRIN112WJ EUDAMED
- EMDN Code
- T020401 STANDARD SURGICAL GOWNS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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
Isolation Gown XL by Hygitech — 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 | 361514H2PRIN112WJ | Class I | Active |
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Manufacturer
- Manufacturer
- Hygitech
- EUDAMED SRN
- FR-MF-000007549
Sources (1)
- EUDAMED e4668271-1cf9-404a-9ca0-4cdc0be19658 61 fields · synced Jul 23, 2026