Detro OPA
by Detro Healthcare Ki̇mya Sanayi̇ Anoni̇m Şi̇rketi̇
Ref S-M.DET.1.0051Model Detro OPA
Active
CE MDR
Valid until
16 Jun 2031
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number868009710TF02GK 08680097100030 | Date23 Jun 2026 | StatusActive |
Certificates
- 2975-MED-2616801 Active
Quality management system EU MDR
- Certifier
- SZUTEST Konformitätsbewertungsstelle GmbH 2975
- Issued
- 17 Jun 2026
- Expires
- 16 Jun 2031
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- Detro OPA, S-M.DET.1.0051
- Primary DI / UDI-DI
- 08680097100030
- Basic UDI-DI
- 868009710TF02GK
- EMDN Code
- D010103 Orthophtalaldehyde for the disinfection of medical devices
- Device Class
- Class IIb
- EU market of registration
- Türkiye
Manufacturer details
- EUDAMED SRN
- TR-MF-000022410
Other devices from Detro Healthcare Ki̇mya Sanayi̇ Anoni̇m Şi̇rketi̇
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Properties
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No