Identity
- Trade Name
- Lumenis LaserLink HS (Haag Sterit/ Spectra) EUDAMEDLaser Link HS FDA UDI
- Generic Name
- Laser adaptor FDA UDI
- Model / Reference
- NA EUDAMED0642-936-01Be EUDAMEDLaser Link HS 532nm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810096330338 EUDAMEDFDA UDI
- Basic UDI-DI
- 081009633PCABF EUDAMED
- 510(k) Number
- K151109 FDA UDI
- FDA Product Code
- GEX FDA UDI
- EMDN Code
- Z12011099 LASER SURGERY INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Laser adaptor FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4810 FDA UDI
- Market of Registration
- Poland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
0642-936-01Be by Lumenis Be, Inc. — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 081009633PCABF | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Lumenis Be Inc
- EUDAMED SRN
- US-MF-000016037
- Authorised Representative
- Lumenis (Germany) GmbH DE-AR-000007699
Sources (3)
- EUDAMED e35f3601-33b8-4b99-b546-9c37c251d170 61 fields · synced Jul 30, 2026
- FDA UDI c1c40fd0-51ef-446c-b231-4a10594c6337 33 fields · synced May 30, 2026
- EUDAMED 5f5b5f24-dfd6-44d2-9cc2-d11d44435a78 61 fields · synced Jul 30, 2026