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Keypoint Focus Module

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref 9033A0701

by Natus Manufacturing Limited

Identity

Trade Name
Keypoint Focus Module EUDAMED
Keypoint FDA UDI
Generic Name
Electromyograph FDA UDI
Device Name
Dantec Keypoint Focus EUDAMED
Keypoint Focus Module FDA UDI
Model / Reference
9033A0701 EUDAMEDFDA UDI
Description
Keypoint Focus Module FDA UDI

Identifiers

Catalog Number
9033A0701 FDA UDI
Primary DI / UDI-DI
00382830049955 EUDAMEDFDA UDI
Basic UDI-DI
038283NA00154EF EUDAMED
510(k) Number
K944547 FDA UDI
FDA Product Code
GWF FDA UDI
EMDN Code
N010199 NEUROPHYSIOLOGY DEVICES - OTHER EUDAMED
GMDN Term
Electromyograph FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
882.1870 FDA UDI
Market of Registration
Ireland 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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Keypoint Focus Module by Natus Manufacturing Limited — Class IIa — 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

Manufacturer
Natus Manufacturing Limited
EUDAMED SRN
IE-MF-000000799

Sources (2)

  • EUDAMED 8908c8b5-b114-4567-8f85-3f2be86856d4 61 fields · synced Jul 9, 2026
  • FDA UDI e7f0bc01-f57d-46cc-b670-9c9621eb0de4 35 fields · synced May 30, 2026