Identity
- Trade Name
- Urodynamics Measurement Tubing FDA UDI
- Generic Name
- Urological pressure monitoring tubing set FDA UDI
- Device Name
- Urodynamics Measurement Tubing EUDAMED
- Model / Reference
- TUB101 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00627825000062 EUDAMEDFDA UDI
- Basic UDI-DI
- 062782502NB EUDAMED
- FDA Product Code
- FEN FDA UDI
- EMDN Code
- Z12160485 URODYNAMICS INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Urological pressure monitoring tubing set FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1620 FDA UDI
- Market of Registration
- Netherlands 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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Ethylene Oxide FDA UDI
Urodynamics Measurement Tubing by Laborie Medical Technologies Corp. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 062782502NB | 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 c4307257-3fa5-49f0-aa65-907a32e88f46 61 fields · synced Jul 28, 2026
- FDA UDI 716b0137-e4cf-4d21-b82d-e6ae62e9bdc5 32 fields · synced May 30, 2026