Identity
- Trade Name
- DuoMode™ EUDAMEDDuoMode Cable FDA UDI
- Generic Name
- Electrical-only medical device connection cable, reusable FDA UDI
- Device Name
- DuoMode Cable EUDAMED
- Model / Reference
- RFX-BAY-DUO-100A EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00685447001096 EUDAMEDFDA UDI
- Basic UDI-DI
- 06854470001PL EUDAMED
- FDA Product Code
- IKD FDA UDI
- EMDN Code
- L0317 GENERAL SURGERY ADAPTERS AND CONNECTORS, REUSABLE 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
- 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
Yes
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
No
FDA UDI
DuoMode™ by Baylis Medical Company Inc. — 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 | 06854470001PL | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Baylis Medical Company Inc.
- EUDAMED SRN
- CA-MF-000024361
- Authorised Representative
- Quality First International OÜ EE-AR-000004308
Sources (2)
- EUDAMED f3d9371b-5ac7-4671-af44-203569f0a7f7 61 fields · synced Jun 19, 2026
- FDA UDI 609c1ddd-194b-4360-b2a3-bf5e03e73526 32 fields · synced May 30, 2026