Identity
- Trade Name
- Mediplus FDA UDI
- Generic Name
- Urodynamic measurement system FDA UDI
- Device Name
- Bladder pressure catheter, 4.5Fr EUDAMEDBladder pressure catheter 4.5fr FDA UDI
- Model / Reference
- 5100 EUDAMEDFDA UDI
- Description
- Bladder pressure catheter 4.5fr FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05055140701664 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05055140701664 EUDAMED
- FDA Product Code
- KGZ FDA UDI
- EMDN Code
- U05030101 URETHRAL PRESSURE PROFILE CATHETERS WITHOUT BALLOON, 1-WAY EUDAMED
- GMDN Term
- Urodynamic measurement system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4200 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Catheter Gauge — 4.5 French FDA UDILength — 200.0 Centimeter FDA UDI
Category: Urodynamic measurement system
Mediplus by Mediplus , Ltd. — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Mediplus , Ltd.
Sources (2)
- FDA UDI 868497db-3e73-412a-a685-5b98ec4a619b 35 fields · synced Jun 11, 2026
- EUDAMED 02461812-f33d-42d6-96ad-291e42e342e5 61 fields · synced Jun 11, 2026