Identity
- Trade Name
- AL1 EUDAMED
- Device Name
- Medical Nd:YAG Laser Therapy Systems EUDAMED
- Model / Reference
- AL1 EUDAMEDNA EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971513122142 EUDAMED
- Basic UDI-DI
- B-06971513122142 EUDAMED
- EMDN Code
- Z12011017 NEODYMIUM SURGICAL LASER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
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
Al1 by Beijing Kes Biology Technology Co., Ltd. — 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-06971513122142 | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Beijing KES Biology Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000002099
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 71494a0b-a0a9-4438-8491-2e571f9e05ac 61 fields · synced Jul 31, 2026