Dr.ANA® disposable balloon inflation devices
by Anni and Anna Limited 3 variants
Ref AA-ID-J2830H-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 | Number489711186IDYD 04897111860755 | Date10 Aug 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- Withdrawn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 balloon inflation devices
- Model / Reference
- AA-ID-J2830H-TB
- Primary DI / UDI-DI
- 04897111860755
- Basic UDI-DI
- 489711186IDYD
- EMDN Code
- C010401020180 Ptca balloon dilatation catheters - accessories
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- HK-MF-000036709
- Authorised representative
- Ellecom GmbH DE-AR-000012869
Other devices from Anni and Anna Limited
Properties
Other properties (12)
- 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
- Measuring Function: No
- Incorporates Medicinal Product: No