Sterilization Pouch
by Hefei Deno Medical Supplies Co., Ltd. 9 variants
Ref DNHFP(90x165mm)Model DNHFP,DNSSP,DNSFR,DNSPB,DNGRP,OR CUSTOMIZED， 150X250mm 200X300mm 250X350mm 300X400mm 400X500mm 500X600mm 57x130mm 70x260mm 90x165mm 90x260mm 135x260mm 135x280mm 155x260mm 190x360mm etc
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 | Number697812347DN01KH | Date11 Dec 2024 | 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- Withdrawn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
- Sterilization Pouch
- Model / Reference
- DNHFP, DNSSP, DNSFR, DNSPB, DNGRP, OR CUSTOMIZED， 150X250mm 200X300mm 250X350mm 300X400mm 400X500mm 500X600mm 57x130mm 70x260mm 90x165mm 90x260mm 135x260mm 135x280mm 155x260mm 190x360mm etc, DNHFP(90x165mm)
- Primary DI / UDI-DI
- 06978123470083, 16978123470080
- Basic UDI-DI
- 697812347DN01KH
- EMDN Code
- S01020101 Flat sterilisation reels, paper/plastic film
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000045108
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Hefei Deno Medical Supplies Co., Ltd.
See all devices from Hefei Deno Medical Supplies Co., Ltd. →
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