Spophy
by Hangzhou Gspmed Medical Appliances Co., Ltd. 9 variants
Ref ZHE HANG XIE BEI 20170252Model Biodegradable
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 | Number69313467DEB001BX 06931346750226 | Date27 Jun 2026 | 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- Withdrawn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
- Cohesive Bandage
- Model / Reference
- Biodegradable, ZHE HANG XIE BEI 20170252
- Primary DI / UDI-DI
- 06931346750226
- Basic UDI-DI
- 69313467DEB001BX
- Direct Marketing DI
- 06931346750226
- EMDN Code
- M0303010201 Elastic fixing bandages, self-adhesive, extensible in one direction
- Device Class
- Class I
- EU market of registration
- Czechia
Manufacturer details
- EUDAMED SRN
- CN-MF-000018891
- Authorised representative
- Prolinx GmbH DE-AR-000005129
Other devices from Hangzhou GspMed Medical Appliances Co., Ltd.
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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