Identity
- Trade Name
- Healerbot EUDAMED
- Device Name
- Healerbot_HA EUDAMEDHealerbot_HM EUDAMED
- Model / Reference
- Healerbot EUDAMED0 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800079500072 EUDAMED08800079500089 EUDAMED
- Basic UDI-DI
- 880007950007CV EUDAMED880007950008CX 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 | 880007950007CV | 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 (2)
- EUDAMED 28fe62a9-de5b-402e-afc5-6676511a5c55 61 fields · synced Jul 15, 2026
- EUDAMED ae42184c-8ed3-4937-a859-2502b8f5f680 61 fields · synced May 17, 2026