Identity
- Trade Name
- dS HiRes Hand/Wrist 16Ch 1.5T EUDAMED
- Device Name
- dS HiRes Hand/Wrist 16Ch 1.5T EUDAMED
- Model / Reference
- 459801728861 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00884838098114 EUDAMED
- Basic UDI-DI
- B-00884838098114 EUDAMED
- EMDN Code
- Z1105018001,Z1105018002,Z1105018099 EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
dS HiRes Hand/Wrist 16Ch 1.5T by Invivo Corporation — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union No Longer Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00884838098114 | Class IIa | No Longer Active |
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Manufacturer
- Manufacturer
- Invivo Corporation
- EUDAMED SRN
- US-MF-000002284
- Authorised Representative
- Philips Medical Systems Nederland B.V. NL-AR-000001422
Sources (1)
- EUDAMED 25b70607-2ea3-4690-8b3a-0efd47577d20 61 fields · synced Jul 26, 2026