Sunmed™ disposable inflation device kits
by Sunny Medical Device (Shenzhen) Co.Ltd 13 variants
Ref SM-ID-F3030HS13-TB
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number694735850008LK 06947358518266 | Date5 Jun 2024 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Disposable inflation device kits
- Model / Reference
- SM-ID-F3030HS13-TB
- Primary DI / UDI-DI
- 06947358518266
- Basic UDI-DI
- 694735850008LK
- EMDN Code
- C010401020180 Ptca balloon dilatation catheters - accessories
- Device Class
- Class IIa
- EU market of registration
- Latvia
Manufacturer details
- EUDAMED SRN
- CN-MF-000022722
- Authorised representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
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Properties
Other properties (11)
- 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
- Incorporates Medicinal Product: No