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Lasermach Diode Laser Hair Removal Device
EUDAMEDClass IIa (EU MDR)
Ref WLE-01 includes Applicator model G1L7510Ref WLE-01 includes Applicator model G1L3010Ref WLE-01 includes Applicator model G1L1010
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 G1L7510 EUDAMEDWLE-01 includes Applicator model G1L3010 EUDAMEDWLE-01 includes Applicator model G1L1010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972978060086 EUDAMED06972978060079 EUDAMED06972978060093 EUDAMED
- Basic UDI-DI
- 697297806006LR00001VQ EUDAMED
- Direct Marketing DI
- 06972978060086 EUDAMED06972978060079 EUDAMED06972978060093 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 (3)
- EUDAMED 3b2defdd-fbab-452f-8db6-fab4abab1064 61 fields · synced Aug 2, 2026
- EUDAMED e9615320-6477-41c3-81ee-5fdfc1d1d692 61 fields · synced May 16, 2026
- EUDAMED 3a9820e1-4715-4a9e-8117-b2774a81e6fa 61 fields · synced May 19, 2026