Sterilization pouch
by Debo Medical Technology (Shijiazhuang) Co., Ltd.
Ref Sterilization rollModel Model: Sterilization roll, self-sealing bag Specification: Length (100-200000) mm x Width (20-600) mm or customized
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 | Number697700234SP01JB 06977002344019 | Date5 Mar 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- Withdrawn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
- Sterilization pouch
- Model / Reference
- Model: Sterilization roll, self-sealing bag Specification: Length (100-200000) mm x Width (20-600) mm or customized, Sterilization roll
- Primary DI / UDI-DI
- 06977002344019
- Basic UDI-DI
- 697700234SP01JB
- EMDN Code
- S01020101 Flat sterilisation reels, paper/plastic film
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000039157
- 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