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UROMED Transurethral Silicone Balloon Catheter for Women
EUDAMEDClass IIb (EU MDR)
Ref 1370.20Ref 1370.22Ref 1091.20Ref 1101.26Ref 1100.12Ref 1100.26Ref 1240.22Ref 1370.16Ref 1091.14Ref 1090.18Ref 1240.20Ref 1101.18Ref 1100.18Ref 1090.16Ref 1240.16Ref 1101.20Ref 1240.12Ref 1370.12Ref 1100.16Ref 1101.22Ref 1240.10Ref 1100.14Ref 1091.18Ref 1100.24
Identity
- Trade Name
- UROMED Transurethral Silicone Balloon Catheter for Women EUDAMEDUROMED Transurethral Silicone Balloon Catheter EUDAMED
- Device Name
- TBC01 EUDAMEDTBC02 EUDAMED
- Model / Reference
- 1370.20 EUDAMED1370.22 EUDAMED1091.20 EUDAMED1101.26 EUDAMED1100.12 EUDAMED1100.26 EUDAMED1240.22 EUDAMED1370.16 EUDAMED1091.14 EUDAMED1090.18 EUDAMED1240.20 EUDAMED1101.18 EUDAMED1100.18 EUDAMED1090.16 EUDAMED1240.16 EUDAMED1101.20 EUDAMED1240.12 EUDAMED1370.12 EUDAMED1100.16 EUDAMED1101.22 EUDAMED1240.10 EUDAMED1100.14 EUDAMED1091.18 EUDAMED1100.24 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250098801485 EUDAMED04250098801515 EUDAMED04250098819190 EUDAMED04250098819855 EUDAMED04250098800310 EUDAMED04250098800525 EUDAMED04250098801218 EUDAMED04250098801423 EUDAMED04250098819107 EUDAMED04250098800044 EUDAMED04250098801188 EUDAMED04250098800587 EUDAMED04250098800402 EUDAMED04250098800013 EUDAMED04250098801126 EUDAMED04250098800617 EUDAMED04250098801065 EUDAMED04250098801362 EUDAMED04250098800372 EUDAMED04250098800648 EUDAMED04250098801034 EUDAMED04250098800341 EUDAMED04250098819169 EUDAMED04250098800495 EUDAMED
- Basic UDI-DI
- 04250098810030EB EUDAMED04250098810034EK EUDAMED
- EMDN Code
- U010201 URETHRAL PROSTATIC AND BLADDER CATHETERS, NELATON, WITH BALLOON EUDAMEDU010299 URETHRAL PROSTATIC AND BLADDER CATHETERS, WITH BALLOON - OTHER EUDAMEDU010206 URETHRAL PROSTATIC AND BLADDER CATHETERS, TIEMANN 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
UROMED Transurethral Silicone Balloon Catheter for Women by UROMED Kurt Drews KG — 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 | 04250098810030EB | Class IIb | Active |
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Manufacturer
- Manufacturer
- UROMED Kurt Drews KG
- EUDAMED SRN
- DE-MF-000006084
Sources (24)
- EUDAMED c5b4005c-4905-4752-b2a1-4748a80fea98 61 fields · synced Oct 6, 2026
- EUDAMED 08c6222c-df95-40e6-9053-d7a69923c1a9 61 fields · synced May 11, 2026
- EUDAMED 622e3e61-11ed-46b7-a617-c05000b8cafa 61 fields · synced May 16, 2026
- EUDAMED b4761dff-3120-42bd-be33-de5ecf0ca276 61 fields · synced May 16, 2026
- EUDAMED 5e6c2726-da68-438c-9563-7d36f71bd22c 61 fields · synced May 16, 2026
- EUDAMED d7a846e0-dbfc-46d2-9e11-f350132d213e 61 fields · synced May 17, 2026
- EUDAMED 859c5353-18ab-471a-9de5-d6f615957d64 61 fields · synced May 17, 2026
- EUDAMED 2c91382c-0567-42c7-97bd-96a73758fa49 61 fields · synced May 17, 2026
- EUDAMED b8dd9798-5d21-4471-8e19-0906b3674508 61 fields · synced May 17, 2026
- EUDAMED 972941c2-cdf3-463a-99a7-1c99317b58c4 61 fields · synced May 17, 2026
- EUDAMED 0ffa1bc8-30d2-417d-bea3-459e0721f54f 61 fields · synced May 17, 2026
- EUDAMED b085d57f-bf26-4edf-883c-373a881e71f6 61 fields · synced May 17, 2026
- EUDAMED e37f9a59-94df-45ad-99b5-b126dfe01a82 61 fields · synced May 18, 2026
- EUDAMED 5e533292-029d-4100-b2ab-bd2fd2238a16 61 fields · synced May 18, 2026
- EUDAMED d2263732-bff7-47cd-97b0-4e3c88fb884f 61 fields · synced May 18, 2026
- EUDAMED e7620fc6-300a-4f03-ad87-368807860c70 61 fields · synced May 18, 2026
- EUDAMED 69623deb-3cc1-4d73-94cc-518657e0ae54 61 fields · synced May 18, 2026
- EUDAMED 592429a8-e167-4c96-9a7c-eabf44c04d7c 61 fields · synced May 18, 2026
- EUDAMED 48e0df55-48c7-4724-a846-c008a01972ab 61 fields · synced May 18, 2026
- EUDAMED 24bc5a5b-d9b1-4b44-922e-c8f9943e617a 61 fields · synced May 18, 2026
- EUDAMED 665680a1-1f2e-456c-9155-277c45b20971 61 fields · synced May 18, 2026
- EUDAMED cd3b7498-97dd-4526-88db-57fdcfa7f147 61 fields · synced May 19, 2026
- EUDAMED e04756f7-a770-46e0-a42f-961606a3201c 61 fields · synced May 19, 2026
- EUDAMED 6f9f916d-1c2e-411e-83bb-98fcd221db90 61 fields · synced May 19, 2026