Identity
- Model / Reference
- SD-DE (1.0 M) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809283076823 EUDAMED
- Basic UDI-DI
- 880928307HUREVEEGLZ EUDAMED
- Direct Marketing DI
- 08809283076823 EUDAMED
- EMDN Code
- N010101,N0101020101,N01010202 EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
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
Sd-De (1.0 M) by HUREV Co., Ltd. — 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 | 880928307HUREVEEGLZ | Class I | Active |
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Manufacturer
- Manufacturer
- HUREV Co., Ltd.
- EUDAMED SRN
- KR-MF-000008401
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 8b6066d8-312b-4887-b7e0-818c7a6e0845 61 fields · synced Jun 18, 2026