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Silicone 3-way Hematuria Catheter
EUDAMEDClass IIb (EU MDR)
Ref 1862-0322 Model 1862-0322Ref 1863-0322Ref 1861-0318Ref 1861-0324Ref 1863-0320
Identity
- Trade Name
- Silicone 3-way Hematuria Catheter EUDAMED
- Device Name
- Silicone 3-way Hematuria Catheter EUDAMED
- Model / Reference
- 1862-0322 EUDAMED1863-0322 EUDAMED1861-0318 EUDAMED1861-0324 EUDAMED1863-0320 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04710961933632 EUDAMED14710961933714 EUDAMED14710961933530 EUDAMED04710961933564 EUDAMED04710961933717 EUDAMED04710961933700 EUDAMED14710961933639 EUDAMED
- Basic UDI-DI
- B-04710961933632 EUDAMEDB-14710961933714 EUDAMEDB-14710961933530 EUDAMEDB-04710961933564 EUDAMEDB-04710961933717 EUDAMEDB-04710961933700 EUDAMEDB-14710961933639 EUDAMED
- EMDN Code
- U020299 URETERAL CATHETERS WITH BALLOON - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Finland EUDAMEDBelgium EUDAMEDFrance 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
Silicone 3-way Hematuria Catheter by Fortune Medical Instrument Corp. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
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-04710961933632 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Fortune Medical Instrument Corp.
- EUDAMED SRN
- TW-MF-000009221
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (7)
- EUDAMED 3d26173e-6fe9-4373-850c-996e6158e5f0 61 fields · synced Jul 29, 2026
- EUDAMED 70d7b9bb-d0d9-4516-ac59-0c1fc5cb22b1 61 fields · synced May 18, 2026
- EUDAMED d90cc96c-d1c8-41cf-8ba6-d3050c20a289 61 fields · synced May 18, 2026
- EUDAMED 175bf74f-45ef-490d-b7c7-ed3d48652c63 61 fields · synced May 18, 2026
- EUDAMED aa10309f-e995-4105-99c9-9e60da5778e1 61 fields · synced May 19, 2026
- EUDAMED 59f347f6-cab0-47fa-8967-bb48715605da 61 fields · synced May 19, 2026
- EUDAMED c6b0bb25-a07f-48e3-af57-0fd46db4c856 61 fields · synced May 19, 2026