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Powerflex Single Use Fiber Delivery Device
EUDAMEDClass IIa (EU MDR)
Ref 1000SERef 365SERef 272SE
Identity
- Trade Name
- POWERFLEX SINGLE USE FIBER DELIVERY DEVICE EUDAMED
- Device Name
- POWERFLEX SINGLE USE FIBER DELIVERY DEVICE EUDAMED
- Model / Reference
- 1000SE EUDAMED365SE EUDAMED272SE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00754015200084 EUDAMED00754015200060 EUDAMED00754015200053 EUDAMED
- Basic UDI-DI
- B-00754015200084 EUDAMEDB-00754015200060 EUDAMEDB-00754015200053 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-00754015200084 | 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 (3)
- EUDAMED a0003362-dc19-4df9-b8ea-3c780d6dafd8 61 fields · synced Jul 17, 2026
- EUDAMED 9d69c995-d34c-44ad-a71a-ba20def09bfc 61 fields · synced May 18, 2026
- EUDAMED 212923ec-3213-420d-954e-ba58bce0711e 61 fields · synced May 19, 2026