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Tearscience Activator Clear (disposable)
EUDAMEDClass IIa (EU MDR)
Ref 0803-5050
Identity
- Trade Name
- TEARSCIENCE ACTIVATOR CLEAR (DISPOSABLE) EUDAMED
- Device Name
- LIPIFLOW SYSTEM ACTIVATORS EUDAMED
- Model / Reference
- 0803-5050 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810051250060 EUDAMED
- Basic UDI-DI
- 859623006a004G8 EUDAMED
- EMDN Code
- Z12120299 THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Tearscience Activator Clear (disposable) by Tearscience, Inc. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 859623006a004G8 | Class IIa | Active |
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Manufacturer
- Manufacturer
- TearScience, Inc.
- EUDAMED SRN
- US-MF-000014446
- Authorised Representative
- AMO Ireland IE-AR-000013513
Sources (1)
- EUDAMED f5a12f1f-2082-49ab-a4f9-ef12d93d33d8 61 fields · synced Jul 16, 2026