Identity
- Trade Name
- Healerbot EUDAMED
- Device Name
- Healerbot_H EUDAMED
- Model / Reference
- Healerbot EUDAMED0 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800079500065 EUDAMED
- Basic UDI-DI
- 880007950006CT EUDAMED
- EMDN Code
- Z120616 ELECTROMECHANICAL SYSTEMS FOR PHYSICAL THERAPY EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Türkiye 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
Healerbot by P&S Robotics Co., Ltd. — 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 | 880007950006CT | Class IIa | Active |
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Manufacturer
- Manufacturer
- P&S Robotics Co., Ltd.
- EUDAMED SRN
- KR-MF-000022157
- Authorised Representative
- Arazy Group GmbH DE-AR-000007685
Sources (1)
- EUDAMED c15d0374-5cb9-41d7-9877-fa67fdbdbcc4 61 fields · synced Jun 17, 2026