Identity
- Trade Name
- Digital Duet TM EUDAMED
- Model / Reference
- NA EUDAMEDGA-0001300 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810096330383 EUDAMED
- Basic UDI-DI
- 081009633SLTDX EUDAMED
- EMDN Code
- Z12011099 LASER SURGERY INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class IIb 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
Ga-0001300 by Lumenis Be, Inc. — Class IIb — 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 | 081009633SLTDX | Class IIb | Active |
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Manufacturer
- Manufacturer
- Lumenis Be Inc
- EUDAMED SRN
- US-MF-000016037
- Authorised Representative
- Lumenis (Germany) GmbH DE-AR-000007699
Sources (2)
- EUDAMED 167e122c-2645-4eff-a1a0-b0637b1861ec 61 fields · synced Jul 11, 2026
- EUDAMED bceabf29-5b67-4e87-a835-fb9fcee94b49 61 fields · synced Jul 11, 2026