Identity
- Trade Name
- ExSys EUDAMEDExSys 308 FDA UDI
- Generic Name
- Dermatological excimer laser system FDA UDI
- Device Name
- ExSys EUDAMEDExcimer light 308 nm system FDA UDI
- Model / Reference
- 1000 EUDAMEDFDA UDI
- Description
- Excimer light 308 nm system FDA UDI
Identifiers
- Catalog Number
- 1000 FDA UDI
- Primary DI / UDI-DI
- +B12510000I EUDAMEDB12510000 FDA UDI
- Basic UDI-DI
- B-+B12510000I EUDAMED
- 510(k) Number
- K150752 FDA UDI
- FDA Product Code
- FTC FDA UDI
- EMDN Code
- Z12040202 PHOTOTHERAPY EQUIPMENT EUDAMED
- GMDN Term
- Dermatological excimer laser system FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4630 FDA UDI
- Market of Registration
- Germany 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
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
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
Category: Red-light phototherapy unit, professional
ExSys by GME German Medical Engineering GmbH — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-+B12510000I | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- GME German Medical Engineering GmbH
- EUDAMED SRN
- DE-MF-000009384
Sources (2)
- EUDAMED 457f8375-00b8-4051-92ee-5cc66b25c0f1 61 fields · synced Oct 1, 2026
- FDA UDI 8ea69e1d-0454-4e63-8046-c6e706cc3499 36 fields · synced May 30, 2026