Identity
- Trade Name
- Duo Kit EUDAMED
- Model / Reference
- Surgical Kits EUDAMEDHY1-0901 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03615140002523 EUDAMED
- Basic UDI-DI
- 361514H2KITS100ISHC EUDAMED
- EMDN Code
- T0202 SURGICAL PROCEDURAL KITS (EXCLUDING SURGICAL INSTRUMENT KITS) 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
Duo Kit 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 | 361514H2KITS100ISHC | Class I | Active |
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Manufacturer
- Manufacturer
- Hygitech
- EUDAMED SRN
- FR-MF-000007549
Sources (1)
- EUDAMED 9aff9f7e-49e5-4d00-ba37-59c658e7781f 61 fields · synced Jun 19, 2026