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Diode Laser Equipment for medical use
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref DIODEModel US450
Identity
- Trade Name
- Globalipl FDA UDI
- Generic Name
- Dermatological diode laser system FDA UDI
- Device Name
- Diode Laser Equipment for medical use EUDAMED
- Model / Reference
- US450 EUDAMEDFDA UDIDIODE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973494934509 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06973494934509 EUDAMED
- FDA Product Code
- GEX FDA UDI
- EMDN Code
- Z12011016 DIODE SURGICAL LASER EUDAMED
- GMDN Term
- Dermatological diode 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
Diode Laser Equipment for medical use by Beijing Globalipl Development Co., Ltd. — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID
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-06973494934509 | 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 69097550-1b67-473f-9d56-6f9b69d516f7 61 fields · synced Jun 20, 2026
- FDA UDI 3828b407-ab85-437a-914d-90eaa4d74e9e 32 fields · synced May 30, 2026