AndraBalloon
by Andramed GmbH Germany EUDAMED
Ref ABXL 22/40-1200, ABXL 32/40-1200, ABXL 18/40-1200, ABXL 14/40-1200, ABL 10/20-1200, ABL 12/40-1200, ABXL 16/60-1200, ABXL 24/40-1200, ABXL 28/40-1200, ABXL 14/20-1200, ABL 12/30-1200, ABXL 14/60-1200, ABXL 20/30-1200, ABXL 26/60-1200, ABXL 18/60-1200, ABXL 18/20-1200, ABXL 32/60-1200, ABXL 20/40-1200, ABL 10/40-1200 EMDN C010402020102
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-04250303700688 | Date4 Feb 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDD Expiring
Specification
- Device Name
- AndraBalloon XL 22/40 Length 1200AndraBalloon XL 32/40 Length 1200AndraBalloon XL 18/40 Length 1200AndraBalloon XL 14/40 Length 1200AndraBalloon L 10/20 Length 1200AndraBalloon L 12/40 Length 1200AndraBalloon XL 16/60 Length 1200AndraBalloon XL 24/40 Length 1200AndraBalloon XL 28/40 Length 1200AndraBalloon XL 14/20 Length 1200AndraBalloon L 12/30 Length 1200AndraBalloon XL 14/60 Length 1200AndraBalloon XL 20/30 Length 1200AndraBalloon XL 26/60 Length 1200AndraBalloon XL 18/60 Length 1200AndraBalloon XL 18/20 Length 1200AndraBalloon XL 32/60 Length 1200AndraBalloon XL 20/40 Length 1200AndraBalloon L 10/40 Length 1200
- Model / Reference
- ABXL 22/40-1200, ABXL 32/40-1200, ABXL 18/40-1200, ABXL 14/40-1200, ABL 10/20-1200, ABL 12/40-1200, ABXL 16/60-1200, ABXL 24/40-1200, ABXL 28/40-1200, ABXL 14/20-1200, ABL 12/30-1200, ABXL 14/60-1200, ABXL 20/30-1200, ABXL 26/60-1200, ABXL 18/60-1200, ABXL 18/20-1200, ABXL 32/60-1200, ABXL 20/40-1200, ABL 10/40-1200
- Primary DI / UDI-DI
- 04250303700688, 04250303700718, 04250303700664, 04250303700640, 04250303703603, 04250303700961, 04250303700756, 04250303703191, 04250303700695, 04250303700480, 04250303702002, 04250303700732, 04250303703702, 04250303703122, 04250303703214, 04250303703238, 04250303700879, 04250303700671, 04250303702996
- Basic UDI-DI
- B-04250303700688, B-04250303700718, B-04250303700664, B-04250303700640, B-04250303703603, B-04250303700961, B-04250303700756, B-04250303703191, B-04250303700695, B-04250303700480, B-04250303702002, B-04250303700732, B-04250303703702, B-04250303703122, B-04250303703214, B-04250303703238, B-04250303700879, B-04250303700671, B-04250303702996
- EMDN Code
- C010402020102 Stent positioning vascular balloon dilatation catheters
- Device Class
- Class IIa
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000005706
Other devices from Andramed GmbH
Properties & raw data
Show properties, registry sources and raw records
Other properties (10)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (19)
- EUDAMED 69d5b37a-8e41-40c7-bfe6-22d835b202b0
- EUDAMED 04250303700718|B-04250303700718
- EUDAMED 04250303700664|B-04250303700664
- EUDAMED 04250303700640|B-04250303700640
- EUDAMED 04250303703603|B-04250303703603
- EUDAMED 04250303700961|B-04250303700961
- EUDAMED 04250303700756|B-04250303700756
- EUDAMED 04250303703191|B-04250303703191
- EUDAMED 04250303700695|B-04250303700695
- EUDAMED 04250303700480|B-04250303700480
- EUDAMED 04250303702002|B-04250303702002
- EUDAMED 04250303700732|B-04250303700732
- EUDAMED 04250303703702|B-04250303703702
- EUDAMED 04250303703122|B-04250303703122
- EUDAMED 04250303703214|B-04250303703214
- EUDAMED 04250303703238|B-04250303703238
- EUDAMED 04250303700879|B-04250303700879
- EUDAMED 04250303700671|B-04250303700671
- EUDAMED 04250303702996|B-04250303702996