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Hygitex Kit
EUDAMEDClass IIa (EU MDR)
Ref HY1-095Model Sterile surgical Kits
by Hygitech
Identity
- Trade Name
- Hygitex Kit EUDAMED
- Model / Reference
- Sterile surgical Kits EUDAMEDHY1-095 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03615140002684 EUDAMED
- Basic UDI-DI
- 361514H2KITS100IIGQ EUDAMED
- EMDN Code
- T0202 SURGICAL PROCEDURAL KITS (EXCLUDING SURGICAL INSTRUMENT KITS) EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
Yes
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
Hygitex Kit by Hygitech — Class IIa — 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 | 361514H2KITS100IIGQ | Class IIa | Active |
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Manufacturer
- Manufacturer
- Hygitech
- EUDAMED SRN
- FR-MF-000007549
Sources (1)
- EUDAMED 013259bb-20b1-43a2-bfd8-ed40a7d5ec60 61 fields · synced Jun 18, 2026