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bio-UMAXX 100% SILIKON FOLEY KATHETER
EUDAMEDClass IIb (EU MDR)
Ref FC06201DPRef FC24210DRef FC10203DPRef FC16230DRef FC18230DRef FC20210DRef FC22230DRef FC08203DPRef FC26210DRef FC14210DRef FC16210DRef FC26230D
Identity
- Trade Name
- bio-UMAXX 100% SILIKON FOLEY KATHETER EUDAMED
- Device Name
- Silicone Foley Catheter EUDAMED
- Model / Reference
- FC06201DP EUDAMEDFC24210D EUDAMEDFC10203DP EUDAMEDFC16230D EUDAMEDFC18230D EUDAMEDFC20210D EUDAMEDFC22230D EUDAMEDFC08203DP EUDAMEDFC26210D EUDAMEDFC14210D EUDAMEDFC16210D EUDAMEDFC26230D EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970675357119 EUDAMED06970675357287 EUDAMED06970675357133 EUDAMED06970675357386 EUDAMED06970675357393 EUDAMED06970675357263 EUDAMED06970675357416 EUDAMED06970675357126 EUDAMED06970675357294 EUDAMED06970675357232 EUDAMED06970675357249 EUDAMED06970675351957 EUDAMED
- Basic UDI-DI
- 697067535IMP2BSNNNSFC00VE EUDAMEDB-06970675357287 EUDAMEDB-06970675357133 EUDAMEDB-06970675357386 EUDAMEDB-06970675357393 EUDAMEDB-06970675357294 EUDAMEDB-06970675357126 EUDAMEDB-06970675357249 EUDAMEDB-06970675357416 EUDAMEDB-06970675357263 EUDAMED
- EMDN Code
- U010299 URETHRAL PROSTATIC AND BLADDER CATHETERS, WITH BALLOON - OTHER 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
Category: Indwelling urethral drainage balloon catheter, non-antimicrobial
bio-UMAXX 100% SILIKON FOLEY KATHETER by Integral Medical Products Co., Ltd. — Class IIb — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Indwelling urethral drainage balloon catheter, non-antimicrobial.
- Sunmed — SunMed · Class II
- Dover — Cardinalhealth · Class II
- Silicone Foley Catheters — Dynarex Corp. · Class II
- RUSCH — TELEFLEX INCORPORATED · Class II
- RUSCH — TELEFLEX INCORPORATED · Class II
- RUSCH — TELEFLEX INCORPORATED · Class II
- Porges Coloplast — Coloplast A/S · Class II
- Latex Foley Catheter — Well Lead Medical Co., Ltd · Class II
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 697067535IMP2BSNNNSFC00VE | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 697067535IMP2BSNNNSFC00VE | Class IIb | Active |
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Manufacturer
- Manufacturer
- Integral Medical Products Co., Ltd.
- EUDAMED SRN
- CN-MF-000009217
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (21)
- EUDAMED 492e4cf9-ca42-430c-b8fd-6ea769f00272 61 fields · synced Sep 17, 2026
- EUDAMED 7c739588-5372-4c2d-a0fe-2eb81589c033 61 fields · synced Jun 18, 2026
- EUDAMED 3de320c4-4a3c-413a-81ba-783d5cc2b252 61 fields · synced Jun 18, 2026
- EUDAMED 2df2475b-fcf4-454c-9d23-cbe8e88cf63d 61 fields · synced Jun 19, 2026
- EUDAMED 738b1ce5-c240-47b8-9d40-b05c4e7ea4de 61 fields · synced Jul 9, 2026
- EUDAMED ef2ea683-76ca-4c24-95ff-fd5f87900473 61 fields · synced Jul 10, 2026
- EUDAMED 1cbd5e10-4ba0-496b-880d-6455d7034889 61 fields · synced Jul 11, 2026
- EUDAMED f29b28d6-6466-4175-93be-81a7e2e9499e 61 fields · synced Jul 11, 2026
- EUDAMED 0390119a-d745-4d16-afb0-04dd7ec57bd9 61 fields · synced Jul 11, 2026
- EUDAMED 85816756-67c2-4d2e-b324-662856e53d6e 61 fields · synced Jul 15, 2026
- EUDAMED 6b04204b-a6cd-42a5-baf5-993ff68f207b 61 fields · synced Jul 16, 2026
- EUDAMED 45dc6fc0-6c0b-4a63-b642-f59e5d048d5f 61 fields · synced Jul 17, 2026
- EUDAMED f6aeaf6a-e800-4c99-9361-e0a31101b94b 61 fields · synced Jul 18, 2026
- EUDAMED 2145bd85-eef5-4260-aa9f-325f2de1058b 61 fields · synced Jul 18, 2026
- EUDAMED 77052bbe-2259-4e5f-8a61-14e86c8487cd 61 fields · synced Jul 18, 2026
- EUDAMED c5852398-e5ee-413e-9351-6efab74b3f82 61 fields · synced Jul 21, 2026
- EUDAMED 1fb39939-2c39-4bd5-9a96-af2af3c50e63 61 fields · synced Jul 21, 2026
- EUDAMED 54a38803-4b7c-4d0d-8edd-bc6153bd030c 61 fields · synced Jul 23, 2026
- EUDAMED 9f0be776-2765-44a8-a6e2-33a733fae051 61 fields · synced Jul 25, 2026
- EUDAMED d9c7928a-87a4-4eab-8346-86ee4e3d650b 61 fields · synced Jul 27, 2026
- EUDAMED 8a545634-5b6c-44c1-9340-37d7e482bdd4 61 fields · synced Sep 17, 2026