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Lasermach Diode Laser Hair Removal Device
EUDAMEDClass IIa (EU MDR)
Ref WLE-01 includes Applicator model G1L8010
Identity
- Trade Name
- Lasermach Diode Laser Hair Removal Device EUDAMED
- Device Name
- Diode Laser Hair Removal Device EUDAMED
- Model / Reference
- WLE-01 includes Applicator model G1L8010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972978060062 EUDAMED
- Basic UDI-DI
- 697297806006LR00001VQ EUDAMED
- Direct Marketing DI
- 06972978060062 EUDAMED
- EMDN Code
- X0501 HIGH INTENSITY ELECTROMAGNETIC RADIATION EMITTING EQUIPMENT WITHOUT AN INTENDED MEDICAL PURPOSE INTENDED FOR USE ON THE HUMAN BODY, FOR SKIN RESURFACING, TATTOO OR HAIR REMOVAL OR OTHER SKIN TREATMENT – LASER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Lasermach Diode Laser Hair Removal Device by Wingderm Electro-Optics Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697297806006LR00001VQ | Class IIa | Active |
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Manufacturer
- Manufacturer
- Wingderm Electro-Optics Ltd.
- EUDAMED SRN
- CN-MF-000007136
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED 4fa8429b-f045-40b2-945b-be959e5e52fb 61 fields · synced Jun 18, 2026