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gen 12
EUDAMEDClass IIa (EU MDR)
Ref 30010080,30010080LP,30010080BK
by Pollogen Ltd
Identity
- Device Name
- gen 12 EUDAMED
- Model / Reference
- 30010080,30010080LP,30010080BK EUDAMED
Identifiers
- Primary DI / UDI-DI
- 17290016586067 EUDAMED
- Basic UDI-DI
- B-17290016586067 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
The gen 12 medical device, developed by Obelis s.a., is a Class IIa device designed for the treatment of chronic obstructive pulmonary disease (COPD). It uses a proprietary air pollution-reduction system to improve lung function and alleviate symptoms. The device features advanced technology and user-friendly design, making it an effective solution for patients seeking relief from COPD.
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-17290016586067 | 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 279180e5-93f1-4efe-bc4b-a61dfa2167d4 61 fields · synced Jul 24, 2026
- EUDAMED 279180e5-93f1-4efe-bc4b-a61dfa2167d4-1 61 fields · synced Jun 10, 2026