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Surgical Drape
EUDAMEDClass I (EU MDR)
Ref HY1-2057Model Sterile Surgical Drapes
by Hygitech
Identity
- Trade Name
- Surgical Drape EUDAMED
- Model / Reference
- Sterile Surgical Drapes EUDAMEDHY1-2057 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03615140014250 EUDAMED
- Basic UDI-DI
- 361514H2PREN122V9 EUDAMED
- EMDN Code
- T020102 SPECIALISTIC SURGERY DRAPES 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
Surgical Drape 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 | 361514H2PREN122V9 | Class I | Active |
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Manufacturer
- Manufacturer
- Hygitech
- EUDAMED SRN
- FR-MF-000007549
Sources (1)
- EUDAMED 3ef1c2ea-37e2-4e81-b888-de872361aeea 61 fields · synced May 23, 2026