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LINC All Silicone
EUDAMEDClass IIb (EU MDR)
Ref 1007UB12OTModel OptiTipRef 1007UBF14OTRef 1007UB18OTHRef 08451405HModel Open TipRef 08471205HRef 08452010HRef 08471205GRef 08452010GRef 08451610GRef 08452410GRef 08501205HRef 085012051HRef 1011UB12HModel Tiemann TipRef 08471610GRef 08471610HRef 1007UB16OTRef 084614051HRef 08451810GRef 08451205HRef 08500803GRef 085014051HRef 08500601HRef 1007UBS10OTHRef 08501610HRef 08471405HRef 1007UBF12OTRef 1007UB18OTRef 08452410HRef 08451610HRef 1011UB18HRef 08501205GRef 08472010HRef 08451810HRef 08500601GRef 1007UBS08OTHRef 08471810HRef 08500803SGRef 1007UBF14OTHRef 085016101GRef 08471003HRef 1007UB12OTHRef 1007UB14OTHRef 084616101H
Identity
- Trade Name
- LINC All Silicone Catheter EUDAMEDLINC All Silicone EUDAMED
- Device Name
- LINC All Silicone EUDAMED
- Model / Reference
- OptiTip EUDAMED1007UB12OT EUDAMED1007UBF14OT EUDAMED1007UB18OTH EUDAMEDOpen Tip EUDAMED08451405H EUDAMED08471205H EUDAMED08452010H EUDAMED08471205G EUDAMED08452010G EUDAMED08451610G EUDAMED08452410G EUDAMED08501205H EUDAMED085012051H EUDAMEDTiemann Tip EUDAMED1011UB12H EUDAMED08471610G EUDAMED08471610H EUDAMED1007UB16OT EUDAMED084614051H EUDAMED08451810G EUDAMED08451205H EUDAMED08500803G EUDAMED085014051H EUDAMED08500601H EUDAMED1007UBS10OTH EUDAMED08501610H EUDAMED08471405H EUDAMED1007UBF12OT EUDAMED1007UB18OT EUDAMED08452410H EUDAMED08451610H EUDAMED1011UB18H EUDAMED08501205G EUDAMED08472010H EUDAMED08451810H EUDAMED08500601G EUDAMED1007UBS08OTH EUDAMED08471810H EUDAMED08500803SG EUDAMED1007UBF14OTH EUDAMED085016101G EUDAMED08471003H EUDAMED1007UB12OTH EUDAMED1007UB14OTH EUDAMED084616101H EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060548240769 EUDAMED05060548240813 EUDAMED05060548241452 EUDAMED05060548241292 EUDAMED05060548241353 EUDAMED05060548241322 EUDAMED05060548240691 EUDAMED05060548240660 EUDAMED05060548240646 EUDAMED05060548240684 EUDAMED05060548241001 EUDAMED05060548241049 EUDAMED05060548241209 EUDAMED05060548240714 EUDAMED05060548241377 EUDAMED05060548240783 EUDAMED05060548241513 EUDAMED05060548240653 EUDAMED05060548241285 EUDAMED05060548240073 EUDAMED05060548241056 EUDAMED05060548240943 EUDAMED05060548241414 EUDAMED05060548241025 EUDAMED05060548241360 EUDAMED05060548240806 EUDAMED05060548240790 EUDAMED05060548241346 EUDAMED05060548241308 EUDAMED05060548241230 EUDAMED05060548240172 EUDAMED05060548241391 EUDAMED05060548241315 EUDAMED05060548240035 EUDAMED05060548241407 EUDAMED05060548241384 EUDAMED05060548240080 EUDAMED05060548241476 EUDAMED05060548240264 EUDAMED05060548241254 EUDAMED05060548241421 EUDAMED05060548241438 EUDAMED05060548241520 EUDAMED
- Basic UDI-DI
- B-05060548240769 EUDAMEDB-05060548240813 EUDAMEDB-05060548241452 EUDAMEDB-05060548241292 EUDAMEDB-05060548241353 EUDAMEDB-05060548241322 EUDAMEDB-05060548240691 EUDAMEDB-05060548240660 EUDAMEDB-05060548240646 EUDAMEDB-05060548240684 EUDAMEDB-05060548241001 EUDAMEDB-05060548241049 EUDAMEDB-05060548241209 EUDAMEDB-05060548240714 EUDAMEDB-05060548241377 EUDAMEDB-05060548240783 EUDAMEDB-05060548241513 EUDAMEDB-05060548240653 EUDAMEDB-05060548241285 EUDAMEDB-05060548240073 EUDAMEDB-05060548241056 EUDAMEDB-05060548240943 EUDAMEDB-05060548241414 EUDAMEDB-05060548241025 EUDAMEDB-05060548241360 EUDAMEDB-05060548240806 EUDAMEDB-05060548240790 EUDAMEDB-05060548241346 EUDAMEDB-05060548241308 EUDAMEDB-05060548241230 EUDAMEDB-05060548240172 EUDAMEDB-05060548241391 EUDAMEDB-05060548241315 EUDAMEDB-05060548240035 EUDAMEDB-05060548241407 EUDAMEDB-05060548241384 EUDAMEDB-05060548240080 EUDAMEDB-05060548241476 EUDAMEDB-05060548240264 EUDAMEDB-05060548241254 EUDAMEDB-05060548241421 EUDAMEDB-05060548241438 EUDAMEDB-05060548241520 EUDAMED
- EMDN Code
- U010299 URETHRAL PROSTATIC AND BLADDER CATHETERS, WITH BALLOON - OTHER EUDAMEDU010206 URETHRAL PROSTATIC AND BLADDER CATHETERS, TIEMANN WITH BALLOON EUDAMEDU010201 URETHRAL PROSTATIC AND BLADDER CATHETERS, NELATON, WITH BALLOON EUDAMEDU010201,U010206 EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Indwelling urethral drainage balloon catheter, non-antimicrobial
LINC All Silicone by LINC Medical Systems Ltd — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Indwelling urethral drainage balloon catheter, non-antimicrobial.
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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-05060548240769 | Class IIb | Active |
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Manufacturer
- Manufacturer
- LINC Medical Systems Ltd
- EUDAMED SRN
- UK-MF-000037544
- Authorised Representative
- MPS Medical Product Service GmbH DE-AR-000005009
Sources (43)
- EUDAMED 25fe908a-63b2-4756-8aa6-ca1576d0d34f 61 fields · synced Oct 6, 2026
- EUDAMED 40c6f2fd-3a6a-4f05-88c3-7698732bc9fb 61 fields · synced May 11, 2026
- EUDAMED 80312689-273d-4b44-a66a-85721f4434e3 61 fields · synced May 16, 2026
- EUDAMED 4601ebac-c358-4069-9fe1-4298e98a29df 61 fields · synced May 16, 2026
- EUDAMED ce4b6873-b1c9-487e-99f3-c73533382910 61 fields · synced May 16, 2026
- EUDAMED e13778b5-6e2d-470d-bfcd-5ae373a8b2ef 61 fields · synced May 17, 2026
- EUDAMED ff5bd9a3-8c84-4aa6-b244-9d49e064537e 61 fields · synced May 17, 2026
- EUDAMED 4b066f44-52a0-4c82-a3aa-461b58a90200 61 fields · synced May 17, 2026
- EUDAMED 3d9a105b-8f58-4181-9545-fb5ba0d65326 61 fields · synced May 17, 2026
- EUDAMED d78d2ecf-032c-452a-bf29-e7d70a2b056b 61 fields · synced May 17, 2026
- EUDAMED ae62fffd-6565-482e-a917-1c9a4601bde9 61 fields · synced May 17, 2026
- EUDAMED 5e8e7c4c-6df2-4bf0-8338-23815b3fc537 61 fields · synced May 17, 2026
- EUDAMED a2a24dae-6600-4c48-9f99-fca8c82a8c68 61 fields · synced May 17, 2026
- EUDAMED c086abee-c484-4bbb-bc05-0ecf429e1781 61 fields · synced May 17, 2026
- EUDAMED e9f5bf0f-eedd-45b7-b119-4d19cd916777 61 fields · synced May 17, 2026
- EUDAMED 88ce7515-1dcf-414c-bdca-a1cdbc4422e9 61 fields · synced May 17, 2026
- EUDAMED ce928192-5542-4755-81fb-a6df70df71fc 61 fields · synced May 17, 2026
- EUDAMED fe558e18-e13c-4cc2-8db4-ffc718586695 61 fields · synced May 17, 2026
- EUDAMED 3164615e-4242-424a-bf88-d406dd54ec6a 61 fields · synced May 17, 2026
- EUDAMED a4046a55-42a9-47fe-a056-89c5b73482b5 61 fields · synced May 18, 2026
- EUDAMED a7c2d44e-9164-4a19-8863-519fc6caa153 61 fields · synced May 18, 2026
- EUDAMED bb33babb-17d7-43d3-b288-e4f386cecdb0 61 fields · synced May 18, 2026
- EUDAMED 629a59fa-c476-48b0-b626-2fa52d7f4081 61 fields · synced May 18, 2026
- EUDAMED d563ded0-4088-43c7-9608-b52788ba64d8 61 fields · synced May 18, 2026
- EUDAMED 2ccd3df0-b369-4659-8ee4-63624ce23f2d 61 fields · synced May 18, 2026
- EUDAMED 453a1262-e801-4c36-8266-f005e985227e 61 fields · synced May 18, 2026
- EUDAMED f965712e-40a5-41c7-93db-70e9d3de7b6f 61 fields · synced May 18, 2026
- EUDAMED ed271704-5a36-4d50-b27f-366c51705aa5 61 fields · synced May 18, 2026
- EUDAMED fb071868-64bc-420f-bf6f-0eb29f73d789 61 fields · synced May 18, 2026
- EUDAMED a92e19cd-7b92-44c1-a583-95f2316d0456 61 fields · synced May 18, 2026
- EUDAMED ace1a249-8a9f-4790-a459-ab3478ee0bfe 61 fields · synced May 18, 2026
- EUDAMED 0a30f556-1ed0-4bdb-a929-c843d4e51418 61 fields · synced May 18, 2026
- EUDAMED 8eebfddb-ac85-44e5-abfa-fd7addfc59d5 61 fields · synced May 18, 2026
- EUDAMED 08b8e17c-8c71-44c4-8b98-09e590f8aa44 61 fields · synced May 18, 2026
- EUDAMED 22431e75-020f-42a8-b514-d387eda3b492 61 fields · synced May 18, 2026
- EUDAMED ceed72ea-5935-4ef8-a8a6-042735d38191 61 fields · synced May 18, 2026
- EUDAMED 936690fc-3ef9-4544-947e-d41fed0e98cb 61 fields · synced May 18, 2026
- EUDAMED d7aa32ec-1110-4f7b-bd86-73a42c6b334d 61 fields · synced May 18, 2026
- EUDAMED 329a0a29-5c31-4de2-9826-5720b32834cb 61 fields · synced May 18, 2026
- EUDAMED c049de59-158b-4333-ba62-46bad0fbf735 61 fields · synced May 18, 2026
- EUDAMED 0f466833-87ee-4d0e-b7b3-9374a076c401 61 fields · synced May 18, 2026
- EUDAMED 326ec1ee-91ba-49b5-a220-61761fa4fb75 61 fields · synced May 19, 2026
- EUDAMED fafc2805-a894-41af-8ed4-c2d89104ec89 61 fields · synced May 19, 2026