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gen36L
EUDAMEDClass IIa (EU MDR)
Ref 30010160,30010160LP,30010160BK
by Pollogen Ltd
Identity
- Device Name
- gen36L EUDAMED
- Model / Reference
- 30010160,30010160LP,30010160BK EUDAMED
Identifiers
- Primary DI / UDI-DI
- 17290016586272 EUDAMED
- Basic UDI-DI
- B-17290016586272 EUDAMED
- EMDN Code
- Z12040285 GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
gen36L by Pollogen Ltd — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-17290016586272 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Pollogen Ltd
- EUDAMED SRN
- IL-MF-000031034
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED 7a20c35b-34fc-4f65-9d91-49a344650127 61 fields · synced Jun 18, 2026
- EUDAMED 7a20c35b-34fc-4f65-9d91-49a344650127-1 61 fields · synced Jun 10, 2026