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Hepta
EUDAMEDClass I (EU MDR)
Ref LED07651VNRef LED07651-ISCRef LED07651Ref LED07651N-ISCRef LED07651NRef LED071001VN
Identity
- Trade Name
- HEPTA EUDAMED
- Device Name
- HEPTA EUDAMED
- Model / Reference
- LED07651VN EUDAMEDLED07651-ISC EUDAMEDLED07651 EUDAMEDLED07651N-ISC EUDAMEDLED07651N EUDAMEDLED071001VN EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03760361831169 EUDAMED03760361831237 EUDAMED03760361831244 EUDAMED03760361831176 EUDAMED03760361831183 EUDAMED03760361831138 EUDAMED
- Basic UDI-DI
- 376036183HEPTAB4 EUDAMED
- EMDN Code
- Z12010702 MOBILE SCIALYTIC LAMPS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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
Hepta by Lid - Sotramet — 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 | 376036183HEPTAB4 | Class I | Active |
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Manufacturer
- Manufacturer
- Lid - Sotramet
- EUDAMED SRN
- FR-MF-000014659
Sources (6)
- EUDAMED 41b6425c-98e7-41fd-93dc-051ce05bc85a 61 fields · synced Jul 24, 2026
- EUDAMED e587aa4a-c679-4f2e-852f-f1c7983c8567 61 fields · synced May 16, 2026
- EUDAMED b2a05224-9b88-46f7-94a2-04019156072a 61 fields · synced May 16, 2026
- EUDAMED 6d85a18e-f91e-4da2-8aa2-ca7e4283ede8 61 fields · synced May 17, 2026
- EUDAMED 42d354d5-4f0c-4dfc-91f9-c0767f693391 61 fields · synced May 17, 2026
- EUDAMED caf9ad57-56e3-4d26-aa5e-ec8c543c6d37 61 fields · synced May 18, 2026