SpO2 Adapter cable
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- SpO2 Adapter cable EUDAMEDOrantech FDA UDI
- Generic Name
- Electrical-only medical device connection cable, reusable FDA UDI
- Device Name
- SpO2 Adapter cable EUDAMEDGE Marquette-Masimo Compatible, 2.4M FDA UDI
- Model / Reference
- SA-005M-03 EUDAMEDSA-015RB-24LS EUDAMEDFDA UDI
- Description
- GE Marquette-Masimo Compatible, 2.4M FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06941691924128 EUDAMED06941691924425 EUDAMEDFDA UDI
- Basic UDI-DI
- 69416919ORANTECH07R3 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
SpO2 Adapter cable by Orantech Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as General-purpose multi-parameter bedside monitor.
- Welch Allyn, Inc. — Welch Allyn, Inc. · Class II
- Welch Allyn, Inc. — Welch Allyn, Inc. · Class II
- Flying-V cuff LARGE — CNSystems Medizintechnik GmbH · Class II
- Expression MR200 Accessories — Philips DS North America LLC · Class II
- LiDCO — LIDCO LIMITED · Class II
- LiDCO — LIDCO LIMITED · Class II
- HemoSphere Alta — Edwards Lifesciences LLC · Class II
- VitaLogik4500 — Mennen Medical, Inc. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69416919ORANTECH07R3 | 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
- Orantech Inc.
- EUDAMED SRN
- CN-MF-000013859
- Authorised Representative
- Medten EU ApS DK-AR-000034434
Sources (3)
- EUDAMED 43fe303e-04be-4501-8981-9c59fc31792c 61 fields · synced Jul 10, 2026
- EUDAMED 5a80c3d8-2872-4847-a0c3-539226c42cea 61 fields · synced May 17, 2026
- FDA UDI 5a5b1ddf-c529-4eb2-9f01-7704d22a4e8f 33 fields · synced May 29, 2026