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Universal Light Handle, for use with ‘Skytron DoVera’ (Camera Replacement Handl…
EUDAMEDClass I (EU MDR)
Ref PS9978Model TF1012Ref PS9974
Identity
- Trade Name
- Universal Light Handle, for use with ‘Skytron DoVera’ (Camera Replacement Handle) EUDAMEDUniversal Light Handle, for use with ‘Skytron DoVera’ EUDAMED
- Device Name
- Universal Light Handles EUDAMED
- Model / Reference
- TF1012 EUDAMEDPS9978 EUDAMEDPS9974 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05051223034643 EUDAMED05051223034612 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 ‘Skytron DoVera’ (Camera Replacement Handl… by Purple Surgical Holdings Limited also known as Purple Surgical…
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 (2)
- EUDAMED 93c00b8a-dd92-4ce3-8afc-6a66038f3ed3 61 fields · synced Oct 6, 2026
- EUDAMED d2d66eb8-abe4-4556-bf8e-30d775cf3334 61 fields · synced May 18, 2026