Identity
- Model / Reference
- CBL-2000 EUDAMEDREF-240150 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-USMF000014446000019SD EUDAMED
- Basic UDI-DI
- B-USMF000014446000019SD EUDAMED
- EMDN Code
- Z12120299 THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
No
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
Ref-240150 by Tearscience, Inc. — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-USMF000014446000019SD | Class I | Active |
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Manufacturer
- Manufacturer
- TearScience, Inc.
- EUDAMED SRN
- US-MF-000014446
- Authorised Representative
- AMO Ireland IE-AR-000013513
Sources (1)
- EUDAMED 820fb27d-b8e5-4291-92fc-1e8dbdd20ae0 61 fields · synced Jul 8, 2026