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T-DOC Air-Charged Single Sensor Catheter, Radiopaque
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref CAT905Model CAT875
Identity
- Trade Name
- T-DOC Air-Charged Single Sensor Catheter, Radiopaque EUDAMEDAir-Charged Single Sensor Catheter, Radiopaque FDA UDI
- Generic Name
- Urodynamic manometric catheter, non-electronic FDA UDI
- Device Name
- T-DOC Air-Charged Catheter EUDAMED
- Model / Reference
- CAT875 EUDAMEDCAT905 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00627825001069 EUDAMEDFDA UDI
- Basic UDI-DI
- 062782504NF EUDAMED
- FDA Product Code
- FEN FDA UDI
- EMDN Code
- Z12160485 URODYNAMICS INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Urodynamic manometric catheter, non-electronic FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1620 FDA UDI
- Market of Registration
- France 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
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
Prescription Use
No
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Radiation Sterilization FDA UDI
T-DOC Air-Charged Single Sensor Catheter, Radiopaque by Laborie Medical Technologies Corp. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 062782504NF | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Laborie Medical Technologies Corp.
- EUDAMED SRN
- US-MF-000022925
- Authorised Representative
- Medical Measurement Systems B.V. NL-AR-000010438
Sources (2)
- EUDAMED e8571d6a-0a15-4cd9-ac7e-bc96e4551596 61 fields · synced Jun 9, 2026
- FDA UDI e3eb4a1e-f8a8-42df-8b25-4232aeb9b55b 33 fields · synced May 30, 2026