Maxicup
Ref AP01-122-99/CHModel Sterile CUP
Maxicup (AP01-122-99/CH) is a Class I device made by CHIRANA T.Injecta, a.s., registered in EUDAMED on 4 Jun 2026 (Basic UDI-DI 858601504STERILECUP08PM) with CE/MDR certificate 2022-MDR/QS-024/B valid until 30 Sep 2027, active as of 22 Oct 2026.
Expiring
CE MDR
Valid until
30 Sep 2027
FDA recalls
Not applicable
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number858601504STERILECUP08PM 08586015041709 | Date4 Jun 2026 | StatusActive |
Official records
- EUDAMED public site 858601504STERILECUP08PM
Certificates
- 2022-MDR/QS-024/B Expiring
Quality management system EU MDR
- Certifier
- 3EC International a.s. 2265
- Issued
- 28 May 2026
- Expires
- 30 Sep 2027
- Reason
- Change approved
Timeline
- Certificate issued EUDAMED 2022-MDR/QS-024/B
- Registered EUDAMED 858601504STERILECUP08PM
- Certificate expires EUDAMED 2022-MDR/QS-024/B
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Expiring
Specification
- Device name
- Sterile CUP for single use
- Model / reference
- Sterile CUP, AP01-122-99/CH
- Primary DI / UDI-DI
- 08586015041709
- Basic UDI-DI
- 858601504STERILECUP08PM
- Direct marketing DI
- 08586015041709
- EMDN code
- A13 Applicators for drugs and medical devices not present in other classes
- Device class
- Class I
- EU registration type
- Standard device
- EU market of registration
- France
Manufacturer details
- EUDAMED SRN
- SK-MF-000003702
Similar devices in this category
Other devices filed under APPLICATORS FOR DRUGS AND MEDICAL DEVICES NOT PRESENT IN OTHER CLASSES.