Identity
- Trade Name
- Single Use Powered Handle, Universal EUDAMED
- Device Name
- Single Use Powered Handle, Universal EUDAMED
- Model / Reference
- PHDS01A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16971418901610 EUDAMED
- Basic UDI-DI
- 69714189001608Y EUDAMED
- EMDN Code
- H020299,H020399 EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
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
Single Use Powered Handle, Universal by IntoCare Medical Technology (Suzhou) 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 | 69714189001608Y | Class IIa | Active |
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Manufacturer
- Manufacturer
- IntoCare Medical Technology (Suzhou) Co., Ltd.
- EUDAMED SRN
- CN-MF-000017686
- Authorised Representative
- Llins Service & Consulting GmbH DE-AR-000009077
Sources (1)
- EUDAMED 69c64b20-c531-422c-a286-c60f4a2374a7 61 fields · synced Jul 15, 2026