Temperature Adapter cable
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- Temperature Adapter cable EUDAMEDOrantech FDA UDI
- Generic Name
- Electrical-only medical device connection cable, reusable FDA UDI
- Device Name
- Temperature Adapter cable EUDAMEDGE Marquette Compatible,Use with Pronk technology, 1.5M FDA UDI
- Model / Reference
- TA-PH-T15 EUDAMEDTAT-PH02-SC03 EUDAMEDTAT-PH01-MD15 EUDAMEDTA-MQ-T15 EUDAMEDFDA UDITA-MQ-YSI70 EUDAMEDTA-P63SB-YSI30 EUDAMED
- Description
- GE Marquette Compatible,Use with Pronk technology, 1.5M FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06941691983774 EUDAMED06941691971054 EUDAMED06941691971023 EUDAMED06941691983781 EUDAMEDFDA UDI06941691984580 EUDAMED06941691947066 EUDAMED
- Basic UDI-DI
- 69416919ORANTECH05QX EUDAMED
- FDA Product Code
- IKD 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
- 890.1175 FDA UDI
- Market of Registration
- Denmark EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: General-purpose multi-parameter bedside monitor
Temperature 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
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69416919ORANTECH05QX | 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 (7)
- EUDAMED 784c4bbf-832f-4e18-9c03-50ea97511ec0 61 fields · synced Jul 26, 2026
- EUDAMED fb37def8-b8b0-4c7c-99ca-d3a50aa03d4c 61 fields · synced May 18, 2026
- EUDAMED 04126887-f856-4077-86f6-dbc09b89ba1a 61 fields · synced May 18, 2026
- EUDAMED 7ad81abc-b3ab-4e39-8359-00491ef6a5ab 61 fields · synced May 18, 2026
- EUDAMED 14232b10-d973-4021-b19f-ff1647a7311a 61 fields · synced May 18, 2026
- EUDAMED 127699ff-507f-4cae-8a1c-48b2b4d6d9cb 61 fields · synced May 19, 2026
- FDA UDI f6f6e409-0ea2-42c1-ab56-5022935ceba9 33 fields · synced May 30, 2026