IControl
by Promisemed Hangzhou Meditech Co., Ltd. 4 variants
Ref IPN-31-6, IPN-32-4, SL-30-18M2, SL-28-18M, BL-30G
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- Withdrawn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 LancetsBlood Lancets
- Model / Reference
- IPN-31-6, IPN-32-4, SL-30-18M2, SL-28-18M, BL-30G
- Primary DI / UDI-DI
- 06975965297120, 06971227403117, 06975965291296, 06971227408822, 06971227408761
- Basic UDI-DI
- 697122740IPNPZ, 697122740SLYU, 697122740BLX9
- Unit of Use DI
- 86975965297126, 86971227403113, 86975965291292, 86971227408828, 86971227408767
- EMDN Code
- A0101010202, V010401, V010402
- Device Class
- Class IIa
- EU market of registration
- SwedenGermany
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