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Universal Light Handle, for use with ‘Amico Pearl & Dr Mach’
EUDAMEDClass I (EU MDR)
Ref PS9964Model TF1012
Identity
- Trade Name
- Universal Light Handle, for use with ‘Amico Pearl & Dr Mach’ EUDAMED
- Device Name
- Universal Light Handles EUDAMED
- Model / Reference
- TF1012 EUDAMEDPS9964 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05051223034605 EUDAMED
- Basic UDI-DI
- 50512230LHANDLE6X EUDAMED
- EMDN Code
- Z12010780 SCIALYTIC LAMP LIGHTING SYSTEMS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Northern Ireland 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
Universal Light Handle, for use with ‘Amico Pearl & Dr Mach’ by Purple Surgical Holdings Limited also known as Purple Surgical International Limited, Purple…
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 | 50512230LHANDLE6X | Class I | Active |
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Manufacturer
- EUDAMED SRN
- GB-MF-000012819
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED 66dff0ff-c80b-4276-af40-cfe3ae42b5f7 61 fields · synced Jun 19, 2026