Heat-Sealing Sterilization Flat（gusseted） Reel
by Anqing Weiruima New Material Technology Co ., Ltd. EUDAMED
Active
Ref 75mmx200m, 100mmx100m, 450mmx200m, 350mmx200m, 550mmx200m, 120mmx200m, 125mmx200m, 380mmx200m, 150mmx100m, 100mmx200m, 400mmx200m, 200mmx100m, 500mmx200m, 300mmx100m, 450mmx100m, 250mmx100m, 55mmx200mModel WRMHR、WRMHG
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697928572HSFR01YY | 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- Withdrawn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
- Heat-Sealing Sterilization Flat（gusseted） Reel
- Model / Reference
- WRMHR、WRMHG, 75mmx200m, 100mmx100m, 450mmx200m, 350mmx200m, 550mmx200m, 120mmx200m, 125mmx200m, 380mmx200m, 150mmx100m, 100mmx200m, 400mmx200m, 200mmx100m, 500mmx200m, 300mmx100m, 450mmx100m, 250mmx100m, 55mmx200m
- Primary DI / UDI-DI
- 06979285723031, 16979285723151, 06979285723116, 06979285723086, 16979285723137, 06979285723055, 06979285723062, 06979285723093, 06979285723161, 06979285723154, 16979285723083, 16979285723045, 16979285723168, 16979285723106, 06979285723178, 16979285723120, 06979285723192, 16979285723212, 16979285723182, 06979285723024
- Basic UDI-DI
- 697928572HSFR01YY
- 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