Identity
- Trade Name
- H-MAN EUDAMED
- Device Name
- H-MAN EUDAMED
- Model / Reference
- V1.0 EUDAMEDNA EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08885020070026 EUDAMEDD-08885020070002Q3 EUDAMED
- Basic UDI-DI
- 888502007HMV10MGV EUDAMEDB-08885020070002Q3 EUDAMED
- EMDN Code
- Z120616 ELECTROMECHANICAL SYSTEMS FOR PHYSICAL THERAPY EUDAMED
Classification
- Device Class
- Class IIa 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
H-Man by Articares Pte Ltd — Class IIa — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 888502007HMV10MGV | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 888502007HMV10MGV | Class IIa | Active |
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Manufacturer
- Manufacturer
- Articares Pte Ltd
- EUDAMED SRN
- SG-MF-000008179
- Authorised Representative
- QAdvis EAR AB SE-AR-000001599
Sources (2)
- EUDAMED b3bc29fd-a154-4377-99f8-9ddba30080a6 61 fields · synced Jul 14, 2026
- EUDAMED 17930814-7833-435e-a6b4-38925e22e41f 61 fields · synced Jul 10, 2026