Identity
- Trade Name
- X61 EUDAMED
- Device Name
- X61 EUDAMED
- Model / Reference
- M610 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04066358200208 EUDAMED
- Basic UDI-DI
- 40663582010M6100000KT EUDAMED
- Direct Marketing DI
- 04066358200208 EUDAMED
- EMDN Code
- Y180939 MODULAR POSTURE SYSTEMS EUDAMED
Classification
- Device Class
- Class I 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
Category: Assistive ergonomic chair, manually-adjusted
X61 by Berollka-aktiv Rollstuhltechnik GmbH — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 40663582010M6100000KT | Class I | Active |
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Manufacturer
- Manufacturer
- Berollka-aktiv Rollstuhltechnik GmbH
- EUDAMED SRN
- DE-MF-000007043
Sources (1)
- EUDAMED b7c57962-0255-4226-a118-fbbfe413a8ce 61 fields · synced Oct 6, 2026