Identity
- Trade Name
- Reusable Powered Handle, Universal EUDAMED
- Device Name
- Reusable Powered Handle, Universal EUDAMED
- Model / Reference
- PHD01A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16971418901641 EUDAMED
- Basic UDI-DI
- 697141890017093 EUDAMED
- EMDN Code
- H020299,H020399 EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Reusable 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 | 697141890017093 | 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 878b1b2f-b6fe-41f2-add9-04e2e9d6c0b0 61 fields · synced Jun 19, 2026