Identity
- Model / Reference
- DE609 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00851289007361 EUDAMED
- Basic UDI-DI
- 0851289007DE609QY EUDAMED
- Direct Marketing DI
- 00851289007361 EUDAMED
- EMDN Code
- Z12040199 GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Sweden 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
De609 by Firefly Global — 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 | 0851289007DE609QY | Class I | Active |
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Manufacturer
- Manufacturer
- Firefly Global
- EUDAMED SRN
- US-MF-000020015
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED 97c2423b-b91a-4d06-b31d-d0517007c360 61 fields · synced Jun 18, 2026