Identity
- Trade Name
- GLOBALIPL EUDAMEDFDA UDI
- Generic Name
- Dermatological carbon dioxide laser system FDA UDI
- Device Name
- CO2 Fractional Laser Equipment EUDAMED
- Model / Reference
- US800 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06973494938026 EUDAMED06973494938002 FDA UDI
- Basic UDI-DI
- B-06973494938026 EUDAMED
- FDA Product Code
- GEX FDA UDI
- EMDN Code
- Z12011005 CARBON DIOXIDE SURGICAL LASER EUDAMED
- GMDN Term
- Dermatological carbon dioxide laser system FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4810 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
Yes
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
No
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Globalipl by Beijing Globalipl Development Co., Ltd. — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
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-06973494938026 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-06973494938026 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Beijing Globalipl Development Co., Ltd
- EUDAMED SRN
- CN-MF-000010924
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (2)
- EUDAMED 7f376478-e573-40df-892a-787836162cad 61 fields · synced May 31, 2026
- FDA UDI d6ae03a7-a393-4cb5-8974-1141a62561c6 32 fields · synced May 29, 2026