VanishPoint Syringe
by Retractable Technologies, Inc. 2 variants
Ref 10641
Active
CE MDR
Valid until
No date given
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number0613703VPsyringeF9 00613703106407 | Date18 Jan 2023 | 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- Withdrawn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
- Model / reference
- 10641
- Primary DI / UDI-DI
- 00613703106407
- Basic UDI-DI
- 0613703VPsyringeF9
- EMDN code
- A02010205 Infusion and irrigation syringes with safety system, single-use
- Device class
- Class IIa
- EU registration type
- Standard device
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- US-MF-000031781
- Authorised representative
- MDSS GmbH DE-AR-000005430
From the manufacturer
Manufacturer's product page: VanishPoint Insulin Syringe
Other devices from Retractable Technologies, Inc.
Properties
Other properties (11)
- Sterilise before use: No
- Implantable: No
- Reusable: No
- Contains latex: No
- Reprocessed single-use device: No
- Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
- Incorporates a substance derived from human blood or plasma: No
- Contains human tissues or cells: No
- Contains animal tissues or cells: No
- Contains endocrine-disrupting substances: No
- Incorporates a medicinal substance: No