Identity
- Trade Name
- Urinary Catheter Fixation Strap EUDAMED
- Device Name
- Urinary Catheter Fixation Strap EUDAMED
- Model / Reference
- 1800-0002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 14711182607163 EUDAMED
- Basic UDI-DI
- B-14711182607163 EUDAMED
- EMDN Code
- U0280 URETERAL CATHETERS AND STENTS - ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Denmark EUDAMED
Clinical & Handling
Sterile
No
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
Urinary Catheter Fixation Strap by Fortune Medical Instrument Corp. — Class I — 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-14711182607163 | Class I | 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 (1)
- EUDAMED 87f0ae14-65d1-4300-813d-112e76287d6f 61 fields · synced Jul 18, 2026