Heat-Sealing Sterilization Flat（gusseted） Reel
by Anqing Weiruima New Material Technology Co ., Ltd. 23 variants
Ref 300mmx100mModel WRMHR、WRMHG
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697928572HSFR01YY 16979285723199 | Date5 Dec 2025 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Heat-Sealing Sterilization Flat（gusseted） Reel
- Model / Reference
- WRMHR、WRMHG, 300mmx100m
- Primary DI / UDI-DI
- 16979285723199
- Basic UDI-DI
- 697928572HSFR01YY
- EMDN Code
- S01010101 Sterilisation pouches, flat, paper/plastic film
- Device Class
- Class I
- EU 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