Identity
- Trade Name
- CBL, SEDIA, P4 EUDAMEDAir-Charged Reusable Cable FDA UDI
- Generic Name
- Air/gas pressure transducer FDA UDI
- Device Name
- Medex Pressure Cable, P1 EUDAMED
- Model / Reference
- CAB1036 EUDAMEDCAB4520P4 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00627825001380 EUDAMEDFDA UDI
- Basic UDI-DI
- 0627825CABA9 EUDAMED
- FDA Product Code
- FEN FDA UDI
- EMDN Code
- U0580 URODYNAMICS DEVICES - ACCESSORIES EUDAMED
- GMDN Term
- Air/gas pressure transducer FDA UDI
Classification
- Device Class
- Class I 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
No
EUDAMEDFDA UDI
Single Use
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Cbl, Sedia, P4 by Laborie Medical Technologies Corp. — Class I — 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 | 0627825CABA9 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Laborie Medical Technologies Corp.
- EUDAMED SRN
- US-MF-000022925
- Authorised Representative
- Medical Measurement Systems B.V. NL-AR-000010438
Sources (2)
- EUDAMED 86fdfae3-4e56-4243-955d-72a58f54fcbe 61 fields · synced Jun 18, 2026
- FDA UDI 8acd441f-45df-420d-a390-d95a03bb96ad 33 fields · synced May 30, 2026