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Isolation Gown L
EUDAMEDFDA UDIClass I (EU MDR)
Ref HY1-50031Model Isolation and Surgical gownsRef HY1-50043
by Hygitech
Identity
- Trade Name
- Isolation Gown L EUDAMEDHYGITECH FDA UDI
- Generic Name
- Surgical gown, single-use FDA UDI
- Device Name
- Isolation and Surgical gowns EUDAMEDStandard isolation gown with cotton cuffs, sterile with polypropylene layer 30g/m². Available in 4 sizes for the best fit: S, M, L, XL EO sterilised with a 3 year shelf-life FDA UDI
- Model / Reference
- Isolation and Surgical gowns EUDAMEDHY1-50031 EUDAMEDHY1-50043 EUDAMEDHY-50031 FDA UDI
- Description
- Standard isolation gown with cotton cuffs, sterile with polypropylene layer 30g/m². Available in 4 sizes for the best fit: S, M, L, XL EO sterilised with a 3 year shelf-life FDA UDI
Identifiers
- Catalog Number
- HY-50031 FDA UDI
- Primary DI / UDI-DI
- 03615140002172 EUDAMEDFDA UDI03615140006620 EUDAMED
- Basic UDI-DI
- 361514H2PRIN112WJ EUDAMED
- FDA Product Code
- LYU FDA UDI
- EMDN Code
- T020401 STANDARD SURGICAL GOWNS EUDAMED
- GMDN Term
- Surgical gown, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4040 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Isolation Gown L by Hygitech — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 361514H2PRIN112WJ | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Hygitech
- EUDAMED SRN
- FR-MF-000007549
Sources (3)
- EUDAMED b3ee48b7-3e60-40ac-b89d-9f909eadbee3 61 fields · synced Jul 19, 2026
- EUDAMED a8638b8f-64b1-4499-a152-74f57123d90c 61 fields · synced May 17, 2026
- FDA UDI fdacf534-06c0-40c6-82ae-61ec026bffe3 34 fields · synced May 30, 2026