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Connection Cable

EUDAMEDFDA UDI

Class I (EU MDR)

Ref 01.13.036357

by Edan Instruments, Inc.

Identity

Trade Name
Connection Cable EUDAMED
Inner press connecting cable FDA UDI
Generic Name
Tocodynamometer probe FDA UDI
Device Name
Connection Cable EUDAMED
Model / Reference
01.13.036357 EUDAMED
Unified,reusable FDA UDI

Identifiers

Primary DI / UDI-DI
06944413802834 EUDAMEDFDA UDI
Basic UDI-DI
69444138ConCableBK EUDAMED
FDA Product Code
HGM FDA UDI
EMDN Code
Z12030280 VITAL SIGNS MONITORING INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
GMDN Term
Tocodynamometer probe FDA UDI

Classification

Device Class
Class I EUDAMED
Class II FDA UDI
Regulation Number
884.2740 FDA UDI
Market of Registration
Germany 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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Connection Cable by Edan Instruments, 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

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Manufacturer

EUDAMED SRN
CN-MF-000009957
Authorised Representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Sources (2)

  • EUDAMED bed70b63-a2fa-40bd-899e-26badf6a5a50 61 fields · synced Jun 19, 2026
  • FDA UDI 417871f2-bc1d-432c-9238-0851fd0aca89 32 fields · synced May 26, 2026