Carefine
by Promisemed Hangzhou Meditech Co., Ltd. 6 variants
Ref IPN31*5, IPN32*5, IPN32*4, IPN30*8, SL-30-18T, IPN31*6, IPN31*8, IPN29*12
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 | Number697122740IPNPZ | Date22 Nov 2021 | 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- Withdrawn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
- Insulin Pen NeedlesSafety Blood Lancets
- Model / Reference
- IPN31*5, IPN32*5, IPN32*4, IPN30*8, SL-30-18T, IPN31*6, IPN31*8, IPN29*12
- Primary DI / UDI-DI
- 06971227401670, 06971227404985, 06971227401700, 06971227404978, 06971227400475, 06971227401687, 06971227401694, 06971227401656, 06975965298554
- Basic UDI-DI
- 697122740IPNPZ, 697122740SLYU
- Unit of Use DI
- 86971227401676, 86971227404981, 86971227404974, 86971227400471, 86971227401683, 86971227401690, 86971227401652, 86975965298550
- EMDN Code
- A0101010202, V010401
- Device Class
- Class IIa
- EU market of registration
- Sweden
Manufacturer details
- EUDAMED SRN
- CN-MF-000008465
- Authorised representative
- Obelis s.a. BE-AR-000000106
Other devices from Promisemed Hangzhou Meditech Co., Ltd.
See all devices from Promisemed Hangzhou Meditech Co., Ltd. →
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
- Measuring Function: No
- Incorporates Medicinal Product: No