STERIKING® LT-Blueline Self-Sealable Pouches
by Wipak Packaging (Changshu) Co., Ltd. 2 variants
Ref LTSS5A
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 | Number697461034ST16010HM 06974610340396 | Date23 Dec 2021 | 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- Withdrawn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
- STERIKING® Pouches and Rolls
- Model / Reference
- LTSS5A
- Primary DI / UDI-DI
- 06974610340396
- Basic UDI-DI
- 697461034ST16010HM
- EMDN Code
- S01010201 Flat sterilisation pouches, tyvek/plastic film
- Device Class
- Class I
- EU market of registration
- Finland
Manufacturer details
- EUDAMED SRN
- CN-MF-000009613
- Authorised representative
- Wipak Oy FI-AR-000009165
Other devices from Wipak Packaging (Changshu) 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