Reusable Rectal Probe
by Medlander Medical Technology Inc. China EUDAMED
Ref MLD R2
EMDN Z12062485
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number6131346CE01 | Date7 Sep 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Certificates
- 6131346CE01 Supplemented
Quality management system EU MDR
- Notified body
- Notified body 0344
- Issued
- 7 Sep 2026
- Expires
- 1 Feb 2031
- Reason
- Add device or group
Specification
- Device Name
- Reusable Rectal Probe
- Model / Reference
- MLD R2
- Primary DI / UDI-DI
- 06970616091980
- Basic UDI-DI
- 697061609RProbe360508T
- EMDN Code
- Z12062485 Biofeedback instruments - consumables
- Device Class
- Class IIa
- Market of Registration
- Romania
Manufacturer details
- EUDAMED SRN
- CN-MF-000017801
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Other devices from Medlander Medical Technology Inc.
Properties & raw data
Show properties, registry sources and raw records
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
Sources (1)
- EUDAMED 74240427-a3f4-47a4-9af9-35fb8869980c