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gen36
EUDAMEDClass IIa (EU MDR)
Ref 30010090, 30010090LP,30010090BK
by Pollogen Ltd
Identity
- Device Name
- gen36 EUDAMED
- Model / Reference
- 30010090, 30010090LP,30010090BK EUDAMED
Identifiers
- Primary DI / UDI-DI
- 17290016586050 EUDAMED
- Basic UDI-DI
- B-17290016586050 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
gen36 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-17290016586050 | 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 a0575358-34a9-4f8a-930f-958789202b4e 61 fields · synced Jun 19, 2026
- EUDAMED a0575358-34a9-4f8a-930f-958789202b4e-1 61 fields · synced Jun 9, 2026