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DECG Legplate Adapter Cables
EUDAMEDClass I (EU MDR)
Ref FDELA-PH01-SGERef FDELA-NT01-SKERef FDELA-GE01-SKERef FDELA-ED01-SPERef FDELA-NT01-SPERef FDELA-GE02-SGERef FDELA-NT01-SGERef FDELA-PH01-SKE06Ref FDELA-PH01-SKERef FDELA-PH01-SGE07Ref FDELA-HL02-SKERef FDELA-HL01-SKERef FDELA-PH01-SPERef FDELA-GE02-SPERef FDELA-PH01-SPE07Ref FDELA-GE01-SPERef FDELA-SL01-SKE
Identity
- Trade Name
- DECG Legplate Adapter Cables EUDAMED
- Device Name
- DECG Legplate Adapter Cables EUDAMED
- Model / Reference
- FDELA-PH01-SGE EUDAMEDFDELA-NT01-SKE EUDAMEDFDELA-GE01-SKE EUDAMEDFDELA-ED01-SPE EUDAMEDFDELA-NT01-SPE EUDAMEDFDELA-GE02-SGE EUDAMEDFDELA-NT01-SGE EUDAMEDFDELA-PH01-SKE06 EUDAMEDFDELA-PH01-SKE EUDAMEDFDELA-PH01-SGE07 EUDAMEDFDELA-HL02-SKE EUDAMEDFDELA-HL01-SKE EUDAMEDFDELA-PH01-SPE EUDAMEDFDELA-GE02-SPE EUDAMEDFDELA-PH01-SPE07 EUDAMEDFDELA-GE01-SPE EUDAMEDFDELA-SL01-SKE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941691955337 EUDAMED06941691974178 EUDAMED06941691955344 EUDAMED06941691981114 EUDAMED06941691974161 EUDAMED06941691965039 EUDAMED06941691974185 EUDAMED06941691955375 EUDAMED06941691955368 EUDAMED06941691970231 EUDAMED06941691957799 EUDAMED06941691955399 EUDAMED06941691955290 EUDAMED06941691955313 EUDAMED06941691968382 EUDAMED06941691955306 EUDAMED06941691981121 EUDAMED
- Basic UDI-DI
- 69416919ORANTECH02QR EUDAMED
- EMDN Code
- Z12080185 PRENATAL DIAGNOSTIC INSTRUMENTS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Denmark EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
DECG Legplate Adapter Cables by Orantech Inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69416919ORANTECH02QR | Class I | Active |
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Manufacturer
- Manufacturer
- Orantech Inc.
- EUDAMED SRN
- CN-MF-000013859
- Authorised Representative
- Medten EU ApS DK-AR-000034434
Sources (17)
- EUDAMED 4e8553d2-c166-496a-bf1a-ab42ee2ff179 61 fields · synced Sep 18, 2026
- EUDAMED ae475eeb-6eb9-4911-a3f3-29ba5aa0e118 61 fields · synced May 16, 2026
- EUDAMED f887080d-dc1f-472d-af03-aecdf26681ce 61 fields · synced May 16, 2026
- EUDAMED bdd66ac5-c9ca-4e87-a0fa-c10792bfe027 61 fields · synced May 16, 2026
- EUDAMED 9dcfcc97-14a3-4ca9-a3df-215bed73674b 61 fields · synced May 17, 2026
- EUDAMED c9597c20-c4f2-4094-8c1f-0082121207f2 61 fields · synced May 17, 2026
- EUDAMED 27b420df-aa01-4f67-828d-2c7fa1db525d 61 fields · synced May 17, 2026
- EUDAMED 65895b8f-c9a0-4671-888f-488397084851 61 fields · synced May 17, 2026
- EUDAMED 5b5351c0-475d-41ee-8336-3826e1d7850c 61 fields · synced May 17, 2026
- EUDAMED 4cee4030-80b5-4948-bf63-88d953c93e42 61 fields · synced May 18, 2026
- EUDAMED 74aaf4be-28f0-4107-b5d1-b4efd1923188 61 fields · synced May 18, 2026
- EUDAMED 68ef61fa-ddbd-46b0-94c3-f2bbdf24d2f5 61 fields · synced May 18, 2026
- EUDAMED 52bc0f0e-2b21-43cd-a7b1-1eaa1929c466 61 fields · synced May 18, 2026
- EUDAMED 90c09fea-54c8-4575-947e-0169d79e4449 61 fields · synced May 18, 2026
- EUDAMED 66e1a51c-9bf3-4ff9-9dbb-e812e869c5f6 61 fields · synced May 18, 2026
- EUDAMED fc32f710-d391-4d89-841a-aeac34cb28e4 61 fields · synced May 19, 2026
- EUDAMED b6d2cb98-c1bd-4690-bfb0-653d33d404d5 61 fields · synced May 19, 2026