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Tango Reflex Neo
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref Tango Reflex NeoRef LT5106-T
Identity
- Trade Name
- Tango Reflex Neo EUDAMEDFDA UDITango Reflex EUDAMED
- Generic Name
- Ophthalmic solid-state laser system FDA UDI
- Device Name
- Tango Reflex Neo EUDAMEDTango EUDAMED
- Model / Reference
- Tango Reflex Neo EUDAMEDFDA UDILT5106-T EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09342395002209 EUDAMEDFDA UDI09342395000298 EUDAMED
- Basic UDI-DI
- B-09342395002209 EUDAMED9342395YAGSLT6M EUDAMED
- 510(k) Number
- K222395 FDA UDI
- FDA Product Code
- HQF FDA UDI
- EMDN Code
- Z12011017 NEODYMIUM SURGICAL LASER EUDAMED
- GMDN Term
- Ophthalmic solid-state laser system FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 886.4390 FDA UDI
- Market of Registration
- France EUDAMEDGermany 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
Tango Reflex Neo by Ellex Medical Pty Ltd — Class IIb — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-09342395002209 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-09342395002209 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Ellex Medical Pty Ltd
- EUDAMED SRN
- AU-MF-000004802
- Authorised Representative
- E C REP LIMITED IE-AR-000003995
Sources (3)
- EUDAMED f933f2ff-9eba-481c-bcc5-4edd83e35970 61 fields · synced Aug 1, 2026
- FDA UDI ba8ad48a-6d51-4d5c-a82e-ab5c459889a2 33 fields · synced May 29, 2026
- EUDAMED 97189bc6-1733-4e6c-a2bc-e5414d2ff50a 61 fields · synced Jul 10, 2026