Barrier Envelope
by Yueying Medical Instruments (Langfang) Co., Ltd.
Ref 17302PEGASUSModel Pro-Sleeve, Barrier film, Headrest Cover,Paper Headrest Cover,Half Chair Cover,Full Chair Cover,Air Water Syringe Sleeve,Turbine Motor Sleeve,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 | Number697878869BARRIERCOVERSVW 06978788692165 | Date29 Jul 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- Withdrawn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
- Barrier Covers
- Model / Reference
- Pro-Sleeve, Barrier film, Headrest Cover, Paper Headrest Cover, Half Chair Cover, Full Chair Cover, Air Water Syringe Sleeve, Turbine Motor Sleeve, etc, 17302PEGASUS
- Primary DI / UDI-DI
- 06978788692165
- Basic UDI-DI
- 697878869BARRIERCOVERSVW
- EMDN Code
- T030199 Covers, instruments and equipment - other
- Device Class
- Class I
- EU market of registration
- Ireland
Manufacturer details
- EUDAMED SRN
- CN-MF-000048844
- 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