Identity
- Trade Name
- POWERFLEX SINGLE USE FIBER DELIVERY DEVICE EUDAMED
- Device Name
- POWERFLEX SINGLE USE FIBER DELIVERY DEVICE EUDAMED
- Model / Reference
- 550SE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00754015200077 EUDAMED
- Basic UDI-DI
- B-00754015200077 EUDAMED
- EMDN Code
- Z12011099 LASER SURGERY INSTRUMENTS - OTHER 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
Powerflex Single Use Fiber Delivery Device by Luvo Medical Technologies Inc — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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-00754015200077 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Luvo Medical Technologies Inc.
- EUDAMED SRN
- CA-MF-000028601
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 38b9b5bc-4d98-4889-8ef5-9d07abaa0462 61 fields · synced Jun 17, 2026