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TibooCath™
EUDAMEDClass I (EU MDR)
Ref TBCN-TOR-0840Model Hydrophilic Urinary Catheter with Water SocketRef TBC30-0840Ref TBC30-1020Ref TBCN-TOR-1220Ref TBCN-TOR-1420Ref TBC30-1440Ref TBCN-TOR-1030Ref TBCN-1440Ref TBCN-1230Ref TBC30-0820Ref TBCN-TOR-1020Ref TBCN-1630Ref TBC30-0620Ref TBC30-TOR-0830Ref TBC30-TOR-1630Ref TBCN-TOR-1240Ref TBCN-TOR-1630Ref TBCN-TOR-0820Ref TBC30-TOR-1440Ref TBCN-TOR-0830Ref TBC30-0630Ref TBCN-1240Ref TBCN-1020Ref TBC30-1430Ref TBC30-TOR-1640Ref TBCN-0820Ref TBC30-1840Ref TBC30-1230Ref TBCN-1040Ref TBC30-TOR-1620Ref TBCN-TOR-1620Ref TBCN-TOR-1040Ref TBC30-TOR-1220Ref TBCN-1620Ref TBCN-1830Ref TBC30-TOR-1230Ref TBC30-TOR-0840
by Geli̇şi̇m Medi̇kal Tibbi̇ Malz. Paz. San. Ve Ti̇c. Ltd. Şti̇.
Identity
- Trade Name
- TibooCath™ EUDAMED
- Device Name
- Sterile Single Use Hydrophilic Urinary Catheter EUDAMED
- Model / Reference
- Hydrophilic Urinary Catheter with Water Socket EUDAMEDTBCN-TOR-0840 EUDAMEDTBC30-0840 EUDAMEDTBC30-1020 EUDAMEDTBCN-TOR-1220 EUDAMEDTBCN-TOR-1420 EUDAMEDTBC30-1440 EUDAMEDTBCN-TOR-1030 EUDAMEDTBCN-1440 EUDAMEDTBCN-1230 EUDAMEDTBC30-0820 EUDAMEDTBCN-TOR-1020 EUDAMEDTBCN-1630 EUDAMEDTBC30-0620 EUDAMEDTBC30-TOR-0830 EUDAMEDTBC30-TOR-1630 EUDAMEDTBCN-TOR-1240 EUDAMEDTBCN-TOR-1630 EUDAMEDTBCN-TOR-0820 EUDAMEDTBC30-TOR-1440 EUDAMEDTBCN-TOR-0830 EUDAMEDTBC30-0630 EUDAMEDTBCN-1240 EUDAMEDTBCN-1020 EUDAMEDTBC30-1430 EUDAMEDTBC30-TOR-1640 EUDAMEDTBCN-0820 EUDAMEDTBC30-1840 EUDAMEDTBC30-1230 EUDAMEDTBCN-1040 EUDAMEDTBC30-TOR-1620 EUDAMEDTBCN-TOR-1620 EUDAMEDTBCN-TOR-1040 EUDAMEDTBC30-TOR-1220 EUDAMEDTBCN-1620 EUDAMEDTBCN-1830 EUDAMEDTBC30-TOR-1230 EUDAMEDTBC30-TOR-0840 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08680495072816 EUDAMED08680495072205 EUDAMED08680495072236 EUDAMED08680495072939 EUDAMED08680495073028 EUDAMED08680495072472 EUDAMED08680495072878 EUDAMED08680495072458 EUDAMED08680495072335 EUDAMED08680495072144 EUDAMED08680495072847 EUDAMED08680495072519 EUDAMED08680495072083 EUDAMED08680495072809 EUDAMED08680495073165 EUDAMED08680495072991 EUDAMED08680495073141 EUDAMED08680495072755 EUDAMED08680495073103 EUDAMED08680495072786 EUDAMED08680495072113 EUDAMED08680495072366 EUDAMED08680495072212 EUDAMED08680495072441 EUDAMED08680495073196 EUDAMED08680495072120 EUDAMED08680495072656 EUDAMED08680495072359 EUDAMED08680495072274 EUDAMED08680495073134 EUDAMED08680495073110 EUDAMED08680495072908 EUDAMED08680495072953 EUDAMED08680495072489 EUDAMED08680495072601 EUDAMED08680495072984 EUDAMED08680495072830 EUDAMED
- Basic UDI-DI
- 868049507UK3U EUDAMED
- EMDN Code
- U01010501 NELATON CATHETERS, SELF-LUBRICATING EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Türkiye 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: Intermittent urethral drainage catheter, non-antimicrobial, single-use
TibooCath™ by Geli̇şi̇m Medi̇kal Tibbi̇ Malz. Paz. San. Ve Ti̇c. Ltd. Şti̇. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Intermittent urethral drainage catheter, non-antimicrobial, single-use.
- Sterile Urinary Catheter for single use — Jiangsu Suyun Medical Materials Co., Ltd. · Class IIa
- hi-slip plus — Wellspect HealthCare · Class I
- TruCath Oasis — H R Pharmaceuticals, Inc. · Class II
- PVC Hydrophilic Urethral Catheter — Chengdu Daxan Innovative Medical Tech. Co., Ltd. · Class II
- Sterile Urinary Catheter for single use — Jiangsu Suyun Medical Materials Co., Ltd. · Class IIa
- HOMECATH — İstem Medikal Tıbbi Cihaz ve Sanayi Ticaret Anonim Şirketi · Class IIa
- BeneCath® — Hangzhou Jimushi Meditech Co., Ltd. · Class II
- HOMECATH — İstem Medikal Tıbbi Cihaz ve Sanayi Ticaret Anonim Şirketi · Class IIa
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 | 868049507UK3U | Class I | Active |
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Manufacturer
- EUDAMED SRN
- TR-MF-000037637
Sources (37)
- EUDAMED 91714d7f-3872-4dde-b079-b34ce251c69e 61 fields · synced Oct 6, 2026
- EUDAMED b3f6e5d5-3b2b-41ed-b9a4-12fd7247b9d6 61 fields · synced May 11, 2026
- EUDAMED e0006471-fc39-4089-a316-8ca72460b371 61 fields · synced May 16, 2026
- EUDAMED 56d150ab-6c49-4d35-a81a-52c14c758b8b 61 fields · synced May 16, 2026
- EUDAMED d1f6d4f8-660e-4937-9fe2-68d0e106e291 61 fields · synced May 16, 2026
- EUDAMED bfe051e8-a652-41db-8238-d825751d2001 61 fields · synced May 16, 2026
- EUDAMED 4735a34e-f716-4d64-8e35-466018ea17cd 61 fields · synced May 16, 2026
- EUDAMED 9fc88ee8-5da0-442c-9fff-5161d5f75967 61 fields · synced May 16, 2026
- EUDAMED 4b6fa8a2-e047-44ea-9f87-e08b812700ff 61 fields · synced May 16, 2026
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- EUDAMED bc51672b-060f-4946-886f-5e03392fd131 61 fields · synced May 16, 2026
- EUDAMED 1e9e4f60-eb0d-41ae-8126-7e2aecbd849a 61 fields · synced May 16, 2026
- EUDAMED bd998789-18d8-4612-a37f-fbd871257392 61 fields · synced May 17, 2026
- EUDAMED 1c359d3f-3502-4f10-9df4-ad8114c7e9cd 61 fields · synced May 17, 2026
- EUDAMED 16c46bb2-46db-4bc3-aa72-6ffb27ed32e0 61 fields · synced May 17, 2026
- EUDAMED 5e5538bc-c5f1-485e-924d-ab19a041b022 61 fields · synced May 17, 2026
- EUDAMED 46ddc497-24d3-470b-ae31-073bbcec452b 61 fields · synced May 17, 2026
- EUDAMED d055ba82-1a4d-4250-992f-b99ba90a48ac 61 fields · synced May 17, 2026
- EUDAMED 7823a47a-a98a-4d36-882b-6d9345f56767 61 fields · synced May 17, 2026
- EUDAMED fb1627f9-1ea1-4d8e-b978-20522498727e 61 fields · synced May 17, 2026
- EUDAMED 06b346c5-0ee8-40a9-b3ce-93b17f13e003 61 fields · synced May 17, 2026
- EUDAMED 15f1ec7d-317a-4eec-91f2-830911a7ff27 61 fields · synced May 17, 2026
- EUDAMED 6c21296a-e389-48fb-8bba-b512e5c93e6d 61 fields · synced May 17, 2026
- EUDAMED 4058b62e-205c-4ed8-b025-daf84550f2bf 61 fields · synced May 17, 2026
- EUDAMED 07b803a9-0eee-45cb-9293-039860c17bc4 61 fields · synced May 17, 2026
- EUDAMED 56b5507d-849d-466d-b090-6b44926374e9 61 fields · synced May 17, 2026
- EUDAMED a4f66c9a-c18c-4e87-9309-1b910d0e6f12 61 fields · synced May 17, 2026
- EUDAMED 5a005ac1-98d1-4155-9cfc-09a196caea6a 61 fields · synced May 18, 2026
- EUDAMED a1933e4e-d143-4446-8434-d1502e5b0482 61 fields · synced May 18, 2026
- EUDAMED dba101fd-96fe-4d08-bd74-d729da2e01e2 61 fields · synced May 18, 2026
- EUDAMED a1fd71a9-7412-4200-8bd3-fb532beecca0 61 fields · synced May 18, 2026
- EUDAMED eec9cf8d-0452-46c4-94fe-8692bcd0c823 61 fields · synced May 18, 2026
- EUDAMED c1e266aa-9d14-49a6-8bb9-5a95e60d7948 61 fields · synced May 18, 2026
- EUDAMED e127af2f-0f3f-4ef6-9894-b57903bf1f1c 61 fields · synced May 18, 2026
- EUDAMED 656c0305-1ecd-4214-a24e-02738bc8ec52 61 fields · synced May 18, 2026
- EUDAMED f0dba435-dd69-4935-af10-e4a9c6d086fa 61 fields · synced May 19, 2026
- EUDAMED 6a696ca2-fab1-4576-86d1-9b33259ce0ed 61 fields · synced May 19, 2026