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Light Handle Cover
EUDAMEDClass I (EU MDR)
Ref 89-940-20-04Model TF-1000Ref PS4611NS1000Model TF1000
Identity
- Trade Name
- Light Handle Cover EUDAMED
- Device Name
- Light Handle Cover EUDAMEDLIGHT HANDLE COVERS EUDAMED
- Model / Reference
- TF-1000 EUDAMED89-940-20-04 EUDAMEDTF1000 EUDAMEDPS4611NS1000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05051223011170 EUDAMED05051223006183 EUDAMED
- Basic UDI-DI
- B-05051223011170 EUDAMED50512230LHCNN EUDAMED
- EMDN Code
- T030102 COVER SHEATHS, INSTRUMENTS AND EQUIPMENTS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain EUDAMEDNorthern Ireland EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMEDEUDAMED
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
Light Handle Cover by Purple Surgical Holdings Limited also known as Purple Surgical International Limited, Purple Surgical UK Limited and Purple Surgical…
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-05051223011170 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-05051223011170 | Class I | Active |
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Manufacturer
- EUDAMED SRN
- GB-MF-000012819
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED fa96b848-9a71-48dd-80c5-51fde3704777 61 fields · synced Oct 6, 2026
- EUDAMED 0075571c-9f43-4aa1-8c08-ce32026c4a42 61 fields · synced May 17, 2026