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Comprehensive treatment device for myopia and amblyopia
EUDAMEDClass I (EU MDR)
Ref BBL2020-02
Identity
- Device Name
- Comprehensive treatment device for myopia and amblyopia EUDAMED
- Model / Reference
- BBL2020-02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973817340017 EUDAMED
- Basic UDI-DI
- 697381734BBL2020GT EUDAMED
- Direct Marketing DI
- 06973817340017 EUDAMED
- EMDN Code
- Z12120299 THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class I 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
Comprehensive treatment device for myopia and amblyopia by GUANGLANG(Hainan) Biotechnology Co., Ltd — Class I — MDR — listed in EUDAMED
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 | 697381734BBL2020GT | Class I | Active |
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Manufacturer
- Manufacturer
- GUANGLANG(Hainan) Biotechnology Co., Ltd
- EUDAMED SRN
- CN-MF-000032260
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (1)
- EUDAMED f82e6b13-f2a4-4cc6-a83f-78da60b44df3 61 fields · synced Jun 20, 2026