Indicator Strip
by Anqing Weiruima New Material Technology Co ., Ltd. EUDAMED
Active
Ref 20mmx140mm Steam Sterilization Strip, change color from Yellow to Black Class4Model WRMSC、WRMEC、WRMPS
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697928572IS01T5 | Date5 Dec 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Device Name
- Indicator Strip
- Model / Reference
- WRMSC、WRMEC、WRMPS, 20mmx140mm Steam Sterilization Strip, change color from Yellow to Black Class4
- Primary DI / UDI-DI
- 06979285725011
- Basic UDI-DI
- 697928572IS01T5
- EMDN Code
- S01010101 Sterilisation pouches, flat, paper/plastic film
- Device Class
- Class I
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000034045
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
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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