← Back to catalogue
Foley Balloon Catheters
EUDAMEDClass IIb (EU MDR)
Ref 1011-18-1Ref 1002UB-14BRef 1007UBS-10Ref 1002UBF-16-1Ref 1003UB-16Ref 1002UB-26Ref 1002UBS-24Ref 1007UBS-18-1Ref 1002UB-20Ref 1011B-14-1Ref 1004-18-1Ref 1039D-26Ref 1037D-24Ref 1011B-14Ref 1007UBF-24Ref 1011-16-1Ref 1003UB-22-1Ref 1007UB-24Ref 1007UB-16OT-1Ref 1002F-22Ref 1011-16Ref 1002-16Ref 1011-18Ref 1002UBS-26Ref 1007UBS-26Ref 1006-24Ref 1011UB-16-1Ref 1007UBS-08OTRef 1007UBS-18OTRef 1007UB-20OTRef 1001-06-1Ref 1007UB-10OT-1Ref 1007UBS-10OT-1Ref 1001F-10-1Ref 1001-06Ref 1001F-10Ref 1006-20Ref 1002UB-22Ref 1001UB-08-1Ref 1038D-24Ref 1001F-08Ref 1007UB-16-1Ref 1011B-20-1Ref 1002UB-12Ref 1014-24Ref 1007UBF-12Ref 1002-16-1Ref 1002F-18Ref 1007UBF-22Ref 1002UB-16Ref 1007UBF-24OT-1
Identity
- Device Name
- Foley Balloon Catheters EUDAMED
- Model / Reference
- 1011-18-1 EUDAMED1002UB-14B EUDAMED1007UBS-10 EUDAMED1002UBF-16-1 EUDAMED1003UB-16 EUDAMED1002UB-26 EUDAMED1002UBS-24 EUDAMED1007UBS-18-1 EUDAMED1002UB-20 EUDAMED1011B-14-1 EUDAMED1004-18-1 EUDAMED1039D-26 EUDAMED1037D-24 EUDAMED1011B-14 EUDAMED1007UBF-24 EUDAMED1011-16-1 EUDAMED1003UB-22-1 EUDAMED1007UB-24 EUDAMED1007UB-16OT-1 EUDAMED1002F-22 EUDAMED1011-16 EUDAMED1002-16 EUDAMED1011-18 EUDAMED1002UBS-26 EUDAMED1007UBS-26 EUDAMED1006-24 EUDAMED1011UB-16-1 EUDAMED1007UBS-08OT EUDAMED1007UBS-18OT EUDAMED1007UB-20OT EUDAMED1001-06-1 EUDAMED1007UB-10OT-1 EUDAMED1007UBS-10OT-1 EUDAMED1001F-10-1 EUDAMED1001-06 EUDAMED1001F-10 EUDAMED1006-20 EUDAMED1002UB-22 EUDAMED1001UB-08-1 EUDAMED1038D-24 EUDAMED1001F-08 EUDAMED1007UB-16-1 EUDAMED1011B-20-1 EUDAMED1002UB-12 EUDAMED1014-24 EUDAMED1007UBF-12 EUDAMED1002-16-1 EUDAMED1002F-18 EUDAMED1007UBF-22 EUDAMED1002UB-16 EUDAMED1007UBF-24OT-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809690080321 EUDAMED08809690070063 EUDAMED08809690070414 EUDAMED08809690083971 EUDAMED08809690070247 EUDAMED08809157670614 EUDAMED08809157673141 EUDAMED08809690080604 EUDAMED08809157670584 EUDAMED08809690081151 EUDAMED08809690080154 EUDAMED08809157671987 EUDAMED08809157671819 EUDAMED08809690071008 EUDAMED08809690070582 EUDAMED08809690080314 EUDAMED08809690080420 EUDAMED08809690070384 EUDAMED08809690080796 EUDAMED08809157670195 EUDAMED08809157670324 EUDAMED08809157670065 EUDAMED08809157670331 EUDAMED08809157673158 EUDAMED08809690070490 EUDAMED08809157670508 EUDAMED08809690081083 EUDAMED08809690070704 EUDAMED08809690070759 EUDAMED08809690070667 EUDAMED08809690080000 EUDAMED08809690080765 EUDAMED08809690080864 EUDAMED08809690081229 EUDAMED08809157670010 EUDAMED08809157670133 EUDAMED08809157670485 EUDAMED08809157670591 EUDAMED08809157678641 EUDAMED08809157671895 EUDAMED08809157670126 EUDAMED08809690080499 EUDAMED08809690081182 EUDAMED08809157670546 EUDAMED08809690071213 EUDAMED08809690070520 EUDAMED08809690080055 EUDAMED08809157670171 EUDAMED08809690070575 EUDAMED08809157670560 EUDAMED08809690081038 EUDAMED
- Basic UDI-DI
- B-08809690080321 EUDAMEDB-08809690070063 EUDAMEDB-08809690070414 EUDAMEDB-08809690083971 EUDAMEDB-08809690070247 EUDAMEDB-08809157670614 EUDAMEDB-08809157673141 EUDAMEDB-08809690080604 EUDAMEDB-08809157670584 EUDAMEDB-08809690081151 EUDAMEDB-08809690080154 EUDAMEDB-08809157671987 EUDAMEDB-08809157671819 EUDAMEDB-08809690071008 EUDAMEDB-08809690070582 EUDAMEDB-08809690080314 EUDAMEDB-08809690080420 EUDAMEDB-08809690070384 EUDAMEDB-08809690080796 EUDAMEDB-08809157670195 EUDAMEDB-08809157670324 EUDAMEDB-08809157670065 EUDAMEDB-08809157670331 EUDAMEDB-08809157673158 EUDAMEDB-08809690070490 EUDAMEDB-08809157670508 EUDAMEDB-08809690081083 EUDAMEDB-08809690070704 EUDAMEDB-08809690070759 EUDAMEDB-08809690070667 EUDAMEDB-08809690080000 EUDAMEDB-08809690080765 EUDAMEDB-08809690080864 EUDAMEDB-08809690081229 EUDAMEDB-08809157670010 EUDAMEDB-08809157670133 EUDAMEDB-08809157670485 EUDAMEDB-08809157670591 EUDAMEDB-08809157678641 EUDAMEDB-08809157671895 EUDAMEDB-08809157670126 EUDAMEDB-08809690080499 EUDAMEDB-08809690081182 EUDAMEDB-08809157670546 EUDAMEDB-08809690071213 EUDAMEDB-08809690070520 EUDAMEDB-08809690080055 EUDAMEDB-08809157670171 EUDAMEDB-08809690070575 EUDAMEDB-08809157670560 EUDAMEDB-08809690081038 EUDAMED
- EMDN Code
- U010206 URETHRAL PROSTATIC AND BLADDER CATHETERS, TIEMANN WITH BALLOON EUDAMEDU010201 URETHRAL PROSTATIC AND BLADDER CATHETERS, NELATON, WITH BALLOON EUDAMEDU010202 URETHRAL PROSTATIC AND BLADDER CATHETERS, COUVELAIRE, WITH BALLOON EUDAMEDU010204 URETHRAL PROSTATIC AND BLADDER CATHETERS, DUFOUR, WITH BALLOON EUDAMEDU010205 URETHRAL PROSTATIC AND BLADDER CATHETERS, MERCIER, WITH BALLOON EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Foley Balloon Catheters by Yushin Medical Co., Ltd. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08809690080321 | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Yushin Medical Co., Ltd.
- EUDAMED SRN
- KR-MF-000010526
- Authorised Representative
- MPS Medical Product Service GmbH DE-AR-000005009
Sources (51)
- EUDAMED 23a4fcdc-db39-4398-bf87-bbfa1de0ca20 61 fields · synced Oct 5, 2026
- EUDAMED 2d38ddec-d9a1-4410-804f-175b84ab001c 61 fields · synced May 11, 2026
- EUDAMED b8bd000a-73ee-416e-82e7-70755f3c6282 61 fields · synced May 11, 2026
- EUDAMED ed4e6f6f-86bc-4d8c-a09a-73de5fcfb567 61 fields · synced May 11, 2026
- EUDAMED f2db5390-b33a-4002-8b2b-8d76b1a7c26a 61 fields · synced May 11, 2026
- EUDAMED 01f55983-e429-4908-a979-31054ea8593f 61 fields · synced May 11, 2026
- EUDAMED 1aa885a3-3558-4fac-b08a-a7c62ef65182 61 fields · synced May 11, 2026
- EUDAMED c84af427-d7ca-406e-8281-c49a95d3955a 61 fields · synced May 16, 2026
- EUDAMED 6665b913-e91e-404e-a275-880428aa7ddd 61 fields · synced May 16, 2026
- EUDAMED 23596ade-e17b-48e2-859d-970e605145f3 61 fields · synced May 16, 2026
- EUDAMED ab19cab9-ff7c-473f-851d-2161ba9742ab 61 fields · synced May 16, 2026
- EUDAMED 52037a4c-3554-400e-9f73-6f092c25dddf 61 fields · synced May 16, 2026
- EUDAMED 779812d6-9d81-4b03-a374-be8ee67fa9fc 61 fields · synced May 16, 2026
- EUDAMED e5379fac-60c2-4747-866c-0065a47eb2e8 61 fields · synced May 16, 2026
- EUDAMED 2e6b3fb8-d86a-4fe8-b993-c56a0aaca24b 61 fields · synced May 16, 2026
- EUDAMED 88a0127b-ea00-40ae-a1ca-41a17bc6e3d8 61 fields · synced May 16, 2026
- EUDAMED 28b9d134-8da2-460d-8b0f-f88b4d9b5ee8 61 fields · synced May 16, 2026
- EUDAMED 1d445efe-b3c7-46e6-8e6f-24cd4f02fd7e 61 fields · synced May 16, 2026
- EUDAMED 210be390-f7d1-44d5-b91b-d058f39c28c1 61 fields · synced May 16, 2026
- EUDAMED 4cfdb13f-ce1e-43d3-96fe-dee39f624b5e 61 fields · synced May 16, 2026
- EUDAMED bdfe2052-b93c-4b53-900e-f6e3a10cb6e0 61 fields · synced May 16, 2026
- EUDAMED 80e01b4a-bd9a-476e-9cf4-4bc39dd5984d 61 fields · synced May 16, 2026
- EUDAMED 49b014c5-29cc-4af0-b1ee-ea945ec8f4d7 61 fields · synced May 16, 2026
- EUDAMED 4af69432-bc1e-4797-9349-bf5af37e7e63 61 fields · synced May 16, 2026
- EUDAMED a302b241-070e-4136-8595-90106cbdb432 61 fields · synced May 16, 2026
- EUDAMED 8f94a2db-81f4-4427-b4b6-6cff680c3ed6 61 fields · synced May 16, 2026
- EUDAMED 8e412622-734d-4f36-9920-9a25207ede2e 61 fields · synced May 16, 2026
- EUDAMED d1dd19ac-4a80-4040-bb77-26fdb3d677ff 61 fields · synced May 16, 2026
- EUDAMED 99119ec6-804b-4139-99b1-f629d7c7a13e 61 fields · synced May 16, 2026
- EUDAMED 4986cdc2-cbb3-41bd-a208-2f29659aa84b 61 fields · synced May 16, 2026
- EUDAMED 04be56e2-6516-447e-98dc-d1631cd48e4a 61 fields · synced May 16, 2026
- EUDAMED 4e8331e5-9ae8-4caa-acbb-266f33fab925 61 fields · synced May 16, 2026
- EUDAMED e584868e-7e83-4b22-80dd-81f106e6accc 61 fields · synced May 16, 2026
- EUDAMED afd08c5e-66ed-4e27-aacb-5b3fe27ae70e 61 fields · synced May 16, 2026
- EUDAMED f43f309a-ee95-447e-bd76-e4d23300bc3e 61 fields · synced May 16, 2026
- EUDAMED 13df17d0-2d96-40e4-9be4-31a164239fed 61 fields · synced May 17, 2026
- EUDAMED 84703dd0-9c01-49f3-9c53-9dcce47084f5 61 fields · synced May 17, 2026
- EUDAMED 86e1cbf4-fc76-4e98-ab6c-8b348dd1d629 61 fields · synced May 17, 2026
- EUDAMED 9352717e-9ae7-43d2-b6b8-28e0f10ba8f7 61 fields · synced May 17, 2026
- EUDAMED cc854ab8-17d0-4c5d-aeaa-67af2746ccb6 61 fields · synced May 17, 2026
- EUDAMED 9dc73251-4660-4617-9f9e-b89af96c5b58 61 fields · synced May 17, 2026
- EUDAMED af549fdf-f424-42a3-9085-974ed3873655 61 fields · synced May 17, 2026
- EUDAMED e08bfa5e-573c-4033-a478-f012287bd0d3 61 fields · synced May 17, 2026
- EUDAMED ca744426-2033-48fd-ad8b-11f88ce04c20 61 fields · synced May 17, 2026
- EUDAMED 4fa052bf-c82d-48f8-9cd0-3324305c6caa 61 fields · synced May 17, 2026
- EUDAMED f7a4afb3-ec48-4339-bc7d-105451365efb 61 fields · synced May 17, 2026
- EUDAMED f8e69e6a-e8c5-4ed1-8e4e-feedbc9ad148 61 fields · synced May 17, 2026
- EUDAMED e6693cbf-2e72-40b0-a23d-33dc28589d09 61 fields · synced May 17, 2026
- EUDAMED fc9729f6-1c69-454c-b684-53ff6306a8ef 61 fields · synced May 17, 2026
- EUDAMED 1402cc3d-9006-4771-9e03-1d7e9b946951 61 fields · synced May 17, 2026
- EUDAMED e15815a2-b005-4e1a-869e-6ce278784e7b 61 fields · synced May 17, 2026