Identity
- Trade Name
- IBP Adapter Cable EUDAMEDInvasive BP Adapter Cable FDA UDI
- Generic Name
- Electrical-only medical device connection cable, reusable FDA UDI
- Device Name
- IBP Adapter Cable EUDAMEDInvasive BP Adapter Cable Philips Compatible,use with Medex-TranStar Pressure Transducer, 4.0m FDA UDI
- Model / Reference
- IBP-PH-MXT40 EUDAMEDFDA UDI
- Description
- Invasive BP Adapter Cable Philips Compatible,use with Medex-TranStar Pressure Transducer, 4.0m FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970706360774 EUDAMEDFDA UDI
- Basic UDI-DI
- 69416919ORANTECH03QT EUDAMED
- 510(k) Number
- K182327 FDA UDI
- FDA Product Code
- DSA FDA UDI
- EMDN Code
- Z1203020285 MULTI-PARAMETER MONITORS - CONSUMABLES EUDAMED
- GMDN Term
- Electrical-only medical device connection cable, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2900 FDA UDI
- Market of Registration
- Denmark 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: General-purpose multi-parameter bedside monitor
IBP Adapter Cable by Orantech Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 | 69416919ORANTECH03QT | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Orantech Inc.
- EUDAMED SRN
- CN-MF-000013859
- Authorised Representative
- Medten EU ApS DK-AR-000034434
Sources (2)
- EUDAMED d9669c74-ace3-4088-b3d6-3e374577b5a9 61 fields · synced Jul 24, 2026
- FDA UDI 82c539fb-d752-47c2-9e5a-ebaa6fbdae81 34 fields · synced May 25, 2026