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Protektor 32 Ear Inserts

EUDAMEDFDA UDI

Class I (EU MDR)

Ref 005562

by Natus Medical Incorporated Dba Excel-Tech Ltd (xltek)

Identity

Trade Name
Protektor 32 Ear Inserts EUDAMED
Natus FDA UDI
Generic Name
Electromyograph FDA UDI
Device Name
Protektor 32 Ear Inserts EUDAMEDFDA UDI
Model / Reference
005562 EUDAMEDFDA UDI
Description
Protektor 32 Ear Inserts FDA UDI

Identifiers

Primary DI / UDI-DI
00382830011013 EUDAMEDFDA UDI
Basic UDI-DI
0382830058995VL EUDAMED
Direct Marketing DI
00382830011013 EUDAMED
510(k) Number
K093304 FDA UDI
FDA Product Code
GWF FDA UDI
EMDN Code
Z12140380 EVOKED POTENTIAL AUDIOMETRY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
GMDN Term
Electromyograph FDA UDI

Classification

Device Class
Class I 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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Protektor 32 Ear Inserts by Natus Medical Incorporated Dba Excel-Tech Ltd (xltek) — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Natus Medical Incorporated Dba Excel-Tech Ltd (xltek)
EUDAMED SRN
CA-MF-000004001
Authorised Representative
Natus Manufacturing Ltd IE-AR-000000884

Sources (2)

  • EUDAMED 9ae04e29-b129-43b1-bf63-4205c3caa020 61 fields · synced Oct 6, 2026
  • FDA UDI 1dbc440d-3af5-4c51-859e-8f2588d801ca 34 fields · synced May 30, 2026