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Dental diode laser
EUDAMEDClass IIb (EU MDR)
Ref PK2F-01Model K2 Finger
by Hulaser
Identity
- Device Name
- Dental diode laser EUDAMED
- Model / Reference
- K2 Finger EUDAMEDPK2F-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-102003KQ EUDAMED
- Basic UDI-DI
- B-102003KQ EUDAMED
- EMDN Code
- Z12011016 DIODE SURGICAL LASER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Romania EUDAMED
Clinical & Handling
Sterile
No
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
Dental diode laser by Hulaser — Class IIb — 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-102003KQ | Class IIb | Active |
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Manufacturer
- Manufacturer
- Hulaser
- EUDAMED SRN
- KR-MF-000008621
- Authorised Representative
- OMC NI MEDICAL LIMITED XI-AR-000019483
Sources (1)
- EUDAMED 38bc5435-f71f-4eb3-b6c5-c8794b189100 61 fields · synced May 23, 2026