Identity
- Device Name
- my formoline EUDAMED
- Model / Reference
- 4260676710320 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260676710320 EUDAMED
- Basic UDI-DI
- 426067671_formolinel112HP EUDAMED
- EMDN Code
- Z12040192 GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Germany 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
my formoline by be-on-market GmbH — Class I — 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 | 426067671_formolinel112HP | Class I | Active |
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Manufacturer
- Manufacturer
- be-on-market GmbH
- EUDAMED SRN
- DE-MF-000006151
Sources (1)
- EUDAMED 69bc1575-6b70-4003-8cd8-d1b2a235363d 61 fields · synced Jul 11, 2026