Identity
- Trade Name
- Retract EUDAMED
- Device Name
- Single Use MicroDissection Handpiece EUDAMED
- Model / Reference
- PMS8001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-5060418456979W8 EUDAMED
- Basic UDI-DI
- B-5060418456979W8 EUDAMED
- EMDN Code
- K0201010501 OPEN ELECTROSURGERY HANDPIECES, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
Yes
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
Category: Open-surgery electrosurgical handpiece/electrode, monopolar, single-use
Retract by Prima Medical Ltd — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-5060418456979W8 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Prima Medical Ltd
- EUDAMED SRN
- UK-MF-000045180
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 3d50f2aa-17af-4654-b72f-e60344738c91 61 fields · synced Jun 20, 2026