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Powerflex Single Use (365se-Rt) Fiber Delivery Device
EUDAMEDClass IIa (EU MDR)
Ref 365SE-RT
Identity
- Trade Name
- POWERFLEX SINGLE USE (365SE-RT) FIBER DELIVERY DEVICE EUDAMED
- Device Name
- POWERFLEX SINGLE USE FIBER DELIVERY DEVICE EUDAMED
- Model / Reference
- 365SE-RT EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00754015200138 EUDAMED
- Basic UDI-DI
- B-00754015200138 EUDAMED
- EMDN Code
- Z12011085 LASER SURGERY INSTRUMENTS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Sweden 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: Varicose vein lasing procedure kit
Powerflex Single Use (365se-Rt) Fiber Delivery Device by Luvo Medical Technologies Inc — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Varicose vein lasing procedure kit.
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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-00754015200138 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Luvo Medical Technologies Inc.
- EUDAMED SRN
- CA-MF-000028601
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 1c2383f4-fd14-4edb-bbc2-3c5ec29f5949 61 fields · synced Aug 2, 2026