Identity
- Trade Name
- IB Lab FROG EUDAMED
- Device Name
- IB Lab FROG EUDAMED
- Model / Reference
- V1.0 EUDAMEDV1.1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09120105730716 EUDAMED09120105730846 EUDAMED
- Basic UDI-DI
- 912010573IBLABFROGRB EUDAMED
- Direct Marketing DI
- 09120105730716 EUDAMED09120105730846 EUDAMED
- EMDN Code
- Z11069092 VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Austria 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
IB Lab FROG by IB Lab GmbH — Class IIa — 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 | 912010573IBLABFROGRB | Class IIa | Active |
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Manufacturer
- Manufacturer
- IB Lab GmbH
- EUDAMED SRN
- AT-MF-000006554
Sources (2)
- EUDAMED f93ccadf-fe56-4742-903b-33c3cbcd7e2e 61 fields · synced Aug 2, 2026
- EUDAMED a9ce9dd0-5b77-43a5-9978-24c41f633520 61 fields · synced May 19, 2026