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tearcheck
EUDAMEDClass IIa (EU MDR)
Ref D036AF001A08AModel tearcheck
by E-Swin Sas
Identity
- Trade Name
- tearcheck EUDAMED
- Device Name
- tearcheck EUDAMED
- Model / Reference
- tearcheck EUDAMEDD036AF001A08A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03662824000436 EUDAMED
- Basic UDI-DI
- 3662824D036AF001A08AUT EUDAMED
- Direct Marketing DI
- 03662824000436 EUDAMED
- EMDN Code
- Z12040199 GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria 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
tearcheck by E-Swin Sas — 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 | 3662824D036AF001A08AUT | Class IIa | Active |
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Manufacturer
- Manufacturer
- E-Swin Sas
- EUDAMED SRN
- FR-MF-000011807
Sources (1)
- EUDAMED b8390e43-4138-4a5d-8824-2295849ac8a7 61 fields · synced Jul 9, 2026