tearcheck
by E-Swin SAS
Ref D036AF001A08AModel tearcheck
tearcheck (D036AF001A08A) is a medical device (EU MDR Class IIa; EMDN category general medicine diagnosis and monitoring instruments) made by E-Swin, registered in EUDAMED on 17 Jun 2026 (Basic UDI-DI 3662824D036AF001A08AUT) with CE/MDR certificate 28620240995 valid until 23 May 2028, active as of 25 Oct 2026.
Active
CE MDR
Valid until
23 May 2028
FDA recalls
Not applicable
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number3662824D036AF001A08AUT 03662824000436 | Date17 Jun 2026 | StatusActive |
Official records
- EUDAMED public site 3662824D036AF001A08AUT
Certificates
- 28620240995 Active
Quality management system EU MDR
- Certifier
- Intertek Medical Notified Body AB 2862
- Issued
- 24 Mar 2026
- Expires
- 23 May 2028
Timeline
- Certificate issued EUDAMED 28620240995
- Registered EUDAMED 3662824D036AF001A08AUT
- Certificate expires EUDAMED 28620240995
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Model / reference
- tearcheck, D036AF001A08A
- Primary DI / UDI-DI
- 03662824000436
- Basic UDI-DI
- 3662824D036AF001A08AUT
- Direct marketing DI
- 03662824000436
- EMDN code
- Z12040199 General medicine diagnosis and monitoring instruments - other
- Device class
- Class IIa
- EU registration type
- Standard device
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- FR-MF-000011807
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