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Sterile Silicone Foley Catheter
EUDAMEDClass IIb (EU MDR)
Ref FC16210D-SPCModel FC12210D-SPC,FC14210D-SPC,FC16210D-SPC,FC18210D-SPC,FC20210D-SPC,FC22210D-SPC,FC24210D-SPC,FC26210D-SPC,FC16230D-SPC,FC18230D-SPC,FC20230D-SPC,FC22230D-SPC,FC24230D-SPC,FC26230D-SPC,FC14210DC-SPC,FC16210DC-SPC,FC18210DC-SPC,and so onRef FC12210DF-SPCRef FC14210DF-SPCRef FC20230D-SPCRef FC16230D-SPCRef FC22210D-SPCRef FC26230D-SPCRef FC26210D-SPCRef FC18210DC-SPCRef FC22230D-SPCRef FC18230D-SPCRef FC18210D-SPCRef FC24210DC-SPCRef FC16210DF-SPCRef FC12210DFModel FC12210DF,FC14210DF,FC16210DF,FC06201DP,FC08203DP,FC10203DP,FC12205D,FC14205D,FC16205D,FC18205D,FC20205D,FC22205D,FC24205D,FC26205D,FC12210D,FC14210D,FC16210D,FC18210D,FC20210D,FC22210D,FC24210D,FC26210D,FC12215D,FC14215D,FC16215D,FC18215D,and so onRef FC14210D-SPCRef FC24210D-SPCRef FC16210DC-SPCRef FC22210DC-SPCRef FC12210D-SPCRef FC24230D-SPC
Identity
- Trade Name
- Sterile Silicone Foley Catheter EUDAMED
- Device Name
- Sterile Silicone Foley Catheter EUDAMED
- Model / Reference
- FC12210D-SPC,FC14210D-SPC,FC16210D-SPC,FC18210D-SPC,FC20210D-SPC,FC22210D-SPC,FC24210D-SPC,FC26210D-SPC,FC16230D-SPC,FC18230D-SPC,FC20230D-SPC,FC22230D-SPC,FC24230D-SPC,FC26230D-SPC,FC14210DC-SPC,FC16210DC-SPC,FC18210DC-SPC,and so on EUDAMEDFC16210D-SPC EUDAMEDFC12210DF-SPC EUDAMEDFC14210DF-SPC EUDAMEDFC20230D-SPC EUDAMEDFC16230D-SPC EUDAMEDFC22210D-SPC EUDAMEDFC26230D-SPC EUDAMEDFC26210D-SPC EUDAMEDFC18210DC-SPC EUDAMEDFC22230D-SPC EUDAMEDFC18230D-SPC EUDAMEDFC18210D-SPC EUDAMEDFC24210DC-SPC EUDAMEDFC16210DF-SPC EUDAMEDFC12210DF,FC14210DF,FC16210DF,FC06201DP,FC08203DP,FC10203DP,FC12205D,FC14205D,FC16205D,FC18205D,FC20205D,FC22205D,FC24205D,FC26205D,FC12210D,FC14210D,FC16210D,FC18210D,FC20210D,FC22210D,FC24210D,FC26210D,FC12215D,FC14215D,FC16215D,FC18215D,and so on EUDAMEDFC12210DF EUDAMEDFC14210D-SPC EUDAMEDFC24210D-SPC EUDAMEDFC16210DC-SPC EUDAMEDFC22210DC-SPC EUDAMEDFC12210D-SPC EUDAMEDFC24230D-SPC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972013965888 EUDAMED06972013966328 EUDAMED06972013966076 EUDAMED06972013966427 EUDAMED06972013966489 EUDAMED06972013965918 EUDAMED06972013965994 EUDAMED06972013966311 EUDAMED06972013965963 EUDAMED06972013965932 EUDAMED06972013966069 EUDAMED06972013966021 EUDAMED06972013965970 EUDAMED06972013965956 EUDAMED06972013966496 EUDAMED06972013966052 EUDAMED06972013966458 EUDAMED06972013966304 EUDAMED06972013965123 EUDAMED06972013965871 EUDAMED06972013966472 EUDAMED06972013966397 EUDAMED06972013965925 EUDAMED06972013966014 EUDAMED06972013966083 EUDAMED06972013966373 EUDAMED06972013966045 EUDAMED06972013965949 EUDAMED06972013965864 EUDAMED06972013966366 EUDAMED09341601008271 EUDAMED09341601008516 EUDAMED09341601008301 EUDAMED09341601002699 EUDAMED09341601002507 EUDAMED09341601008530 EUDAMED09341601008523 EUDAMED09341601008288 EUDAMED
- Basic UDI-DI
- 697201396MU2BSNNNSSF004RG EUDAMED697201396MU2ASNNNSSF004QH EUDAMED697201396MU2BSNNNSSF001RA EUDAMED
- Direct Marketing DI
- 06972013965888 EUDAMED06972013966328 EUDAMED06972013966076 EUDAMED06972013966427 EUDAMED06972013966489 EUDAMED06972013965918 EUDAMED06972013965994 EUDAMED06972013966311 EUDAMED06972013965963 EUDAMED06972013965932 EUDAMED06972013966069 EUDAMED06972013966021 EUDAMED06972013965970 EUDAMED06972013965956 EUDAMED06972013966496 EUDAMED06972013966052 EUDAMED06972013966458 EUDAMED06972013966304 EUDAMED06972013965123 EUDAMED06972013965871 EUDAMED06972013966472 EUDAMED06972013966397 EUDAMED06972013965925 EUDAMED06972013966014 EUDAMED06972013966083 EUDAMED06972013966373 EUDAMED06972013966045 EUDAMED06972013965949 EUDAMED06972013965864 EUDAMED06972013966366 EUDAMED
- EMDN Code
- U040199 DEVICES FOR SUPRAPUBIC URINARY DRAINAGE - OTHER EUDAMEDU010299 URETHRAL PROSTATIC AND BLADDER CATHETERS, WITH BALLOON - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMEDClass IIa 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
Sterile Silicone Foley Catheter by Multigate Co., Ltd — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697201396MU2BSNNNSSF004RG | Class IIb | Active |
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Manufacturer
- Manufacturer
- Multigate Co., Ltd
- EUDAMED SRN
- CN-MF-000002513
- Authorised Representative
- RFX+Care International A/S DK-AR-000001768
Sources (51)
- EUDAMED 0c81f071-d25a-4c2f-91cc-89b2e6361e2f 61 fields · synced Oct 10, 2026
- EUDAMED 9fc1ab31-209d-44ef-8956-ba32c420cad6 61 fields · synced May 11, 2026
- EUDAMED e796af5a-3863-48f7-bc12-13987ba11797 61 fields · synced May 11, 2026
- EUDAMED c4cbc5b9-be3e-44d8-abcd-45bc7009cd0a 61 fields · synced May 16, 2026
- EUDAMED ed6f98b2-b519-42bc-a106-541bedf79d93 61 fields · synced May 16, 2026
- EUDAMED 278074d2-cfb2-40fd-a7f0-1de69e60f9e5 61 fields · synced May 16, 2026
- EUDAMED b668b3d5-82f4-4606-a819-f96167ea5e0a 61 fields · synced May 16, 2026
- EUDAMED 40913895-293c-49f0-b4a0-64b126f52c2e 61 fields · synced May 16, 2026
- EUDAMED 3c44e34b-c2a8-4e4e-972f-5560bd482991 61 fields · synced May 17, 2026
- EUDAMED b20188cb-f5ac-4a8f-a7f7-0fc74b1856ab 61 fields · synced May 17, 2026
- EUDAMED d986b5c4-87a5-4c9b-b585-ad36d6ae0a15 61 fields · synced May 17, 2026
- EUDAMED b8a10fee-2055-4675-8020-d5799ba89e80 61 fields · synced May 17, 2026
- EUDAMED 0d44d98c-3e70-4d06-b1bf-50da9a9d8cbc 61 fields · synced May 17, 2026
- EUDAMED 2a65eac6-4980-4a0a-9ae7-00752548ab58 61 fields · synced May 17, 2026
- EUDAMED c2469518-40b1-4120-87f9-3d0b9530c803 61 fields · synced May 17, 2026
- EUDAMED 3a42b18e-d182-4d29-b209-e43a0ab3a64b 61 fields · synced May 17, 2026
- EUDAMED 58247cdd-4d34-433f-90df-8c7f8b0868be 61 fields · synced May 17, 2026
- EUDAMED f1b6d267-4803-447e-bdbf-12e47a33852a 61 fields · synced May 17, 2026
- EUDAMED b1099898-ef7b-4069-8df1-c8ccd62438db 61 fields · synced May 17, 2026
- EUDAMED e7486de5-7f4b-4a9b-a281-6043fbbfc592 61 fields · synced May 18, 2026
- EUDAMED 8765197c-b5ea-4eb7-ac46-98652f768d52 61 fields · synced May 18, 2026
- EUDAMED 4f9c1448-134e-4c19-abac-9af0be66c373 61 fields · synced May 19, 2026
- EUDAMED 78eb4336-3309-4617-aaa0-789ecf778db4 61 fields · synced May 19, 2026
- EUDAMED 8e4ae571-6d9a-47e8-a1ba-bb0be80754db 61 fields · synced May 19, 2026
- EUDAMED ae108435-a1d8-4cb7-af33-512e96f31f44 61 fields · synced May 19, 2026
- EUDAMED e2bc168a-48ef-472f-a29f-7f01e345b503 61 fields · synced May 19, 2026
- EUDAMED 498a0760-eff2-456e-aea4-bc5acf875602 61 fields · synced May 19, 2026
- EUDAMED 7d2b4738-74b8-4030-b7d3-327a87522cce 61 fields · synced May 19, 2026
- EUDAMED c8584782-0e99-4b33-ac62-05524d13728f 61 fields · synced May 19, 2026
- EUDAMED 4394774c-9410-4661-8246-e0edf28f934d 61 fields · synced May 19, 2026
- EUDAMED a94adf44-7513-4ab7-ae72-c5a640c76529 61 fields · synced Jun 20, 2026
- EUDAMED 12548297-2770-4b7a-938c-8fc88b15419a 61 fields · synced Jun 20, 2026
- EUDAMED f42303c8-f9e6-4cbc-92f3-29565688e79e 61 fields · synced Jun 20, 2026
- EUDAMED b12e92c8-1ca1-4f2f-ae7c-69e56aa9f4f9 61 fields · synced Jul 9, 2026
- EUDAMED 64581053-288b-4fbe-a119-d1ea7b8a87cb 61 fields · synced Jul 9, 2026
- EUDAMED 6fa98ba6-326b-4ca7-8b4d-e3b165f59fb8 61 fields · synced Jul 9, 2026
- EUDAMED 81961829-80af-4f28-9cb8-55428ed5f335 61 fields · synced Jul 11, 2026
- EUDAMED 09badb72-176c-42ee-b93b-29685066b3dd 61 fields · synced Jul 12, 2026
- EUDAMED 46dabfcb-9eb4-44bc-bdff-04d91891a480 61 fields · synced Jul 12, 2026
- EUDAMED 9c3504fb-d2c8-4550-a116-a5860bbf346c 61 fields · synced Jul 12, 2026
- EUDAMED acd7c0e3-2817-436a-857a-8da6a2ace98d 61 fields · synced Jul 14, 2026
- EUDAMED 17b68f8c-179b-40c9-96c4-f85348f51641 61 fields · synced Jul 14, 2026
- EUDAMED 876cbf5c-8d12-442e-b211-de983e2a497e 61 fields · synced Jul 14, 2026
- EUDAMED d22f6c33-530c-40ff-a435-62b560253bcb 61 fields · synced Jul 15, 2026
- EUDAMED 2022de55-adb9-4614-972b-9648700edfcb 61 fields · synced Jul 15, 2026
- EUDAMED 1f948df4-6ff1-4df4-895b-a901e02b16b4 61 fields · synced Jul 15, 2026
- EUDAMED dd2c4de1-43ea-4704-b10a-5efa025b47d3 61 fields · synced Jul 16, 2026
- EUDAMED 99f1d697-5235-4411-9666-ea6305de4619 61 fields · synced Jul 16, 2026
- EUDAMED ea29e3bd-03c4-4cb1-b54e-4909f5f4d4c5 61 fields · synced Jul 16, 2026
- EUDAMED d6b12d09-7d03-4121-91f2-d94f464a6ba6 61 fields · synced Jul 18, 2026
- EUDAMED 056ce371-8a14-4dc3-bd6d-9086bf6101d7 61 fields · synced Jul 20, 2026