Identity
- Trade Name
- Kit Obesidad + Hiato EUDAMED
- Device Name
- Agrupaciones Laparoscópicas IIb EUDAMED
- Model / Reference
- LAP-002X EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08434048530304 EUDAMED
- Basic UDI-DI
- 843404825KITLAPAROSIIBKB EUDAMED
- EMDN Code
- K0201011102 LAPAROSCOPIC AND THORACOSCOPIC ELECTROSURGERY INSTRUMENT KITS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Medical Purpose
- Procedure packs that bring together some of the disposable devices needed to carry out laparoscopic surgeries including electrosurgical instrument to retrieve and handle soft tissues into class IIb, with different configurations according to the needs of the services and centres EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Kit Obesidad + Hiato by Prim S.a. — Class IIb — 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 | 843404825KITLAPAROSIIBKB | Class IIb | Active |
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Manufacturer
- Manufacturer
- Prim, S.a.
- EUDAMED SRN
- ES-PR-000004648
Sources (1)
- EUDAMED 99448773-6b18-410f-ba1d-196b1e65cce2 61 fields · synced Jun 18, 2026