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Powerflex Reusable Fiber Delivery Device
EUDAMEDClass IIa (EU MDR)
Ref 1000RRef 272RRef 550RRef 365R
Identity
- Trade Name
- POWERFLEX REUSABLE FIBER DELIVERY DEVICE EUDAMED
- Device Name
- POWERFLEX REUSABLE FIBER DELIVERY DEVICE EUDAMED
- Model / Reference
- 1000R EUDAMED272R EUDAMED550R EUDAMED365R EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00754015200046 EUDAMED00754015200015 EUDAMED00754015200039 EUDAMED00754015200022 EUDAMED
- Basic UDI-DI
- B-00754015200046 EUDAMEDB-00754015200015 EUDAMEDB-00754015200039 EUDAMEDB-00754015200022 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
Yes
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 Reusable 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-00754015200046 | 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 (4)
- EUDAMED 044d6d2f-6091-42a7-8a27-0d86c759ead1 61 fields · synced Jul 13, 2026
- EUDAMED 2b257a88-b79f-4f7f-ab00-1548751ba313 61 fields · synced May 16, 2026
- EUDAMED 23e5998e-9e68-41e3-8ad2-7240fc63d257 61 fields · synced May 16, 2026
- EUDAMED d411771c-90e0-407b-85c5-2c0645f74f69 61 fields · synced May 17, 2026