Post-operative compression garment
by Guangzhou Shixing Industrial Co., Ltd. 310 variants
Ref BL6047Model BL8629-3,BL8629-4,BL8695,BL8657,BL860220,BL8615,BL8618,BL8629,AL8709,AL8710,AL8805,AL8815,AL8401,AL8402,AL8403,AL8504,AL8501,AL8814,AL8806, BL86628,BL86625,BL86622,BL86627,BL86624,BL8649-2,BL8620,BL86617,BL86618,BL86616,BL86615,BL8664-2,BL8649-1, 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 | Number697635811PCG001JM 06976358111825 | Date7 Nov 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- Withdrawn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
- Post-operative compression garment
- Model / Reference
- BL8629-3, BL8629-4, BL8695, BL8657, BL860220, BL8615, BL8618, BL8629, AL8709, AL8710, AL8805, AL8815, AL8401, AL8402, AL8403, AL8504, AL8501, AL8814, AL8806, BL86628, BL86625, BL86622, BL86627, BL86624, BL8649-2, BL8620, BL86617, BL86618, BL86616, BL86615, BL8664-2, BL8649-1, etc, BL6047
- Primary DI / UDI-DI
- 06976358111825
- Basic UDI-DI
- 697635811PCG001JM
- EMDN Code
- Y090399 Clothes, footwear and covers for prostheses - other
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000050202
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Guangzhou Shixing Industrial Co., Ltd.
See all devices from Guangzhou Shixing Industrial 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