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Ear Tip ET-11 Pack/50 pcs.

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref 100125-100

by PATH medical GmbH

Identity

Trade Name
ET-11 EUDAMED
Ear Tip ET-11 Pack/50 pcs. FDA UDI
1077 EARTIP 12-16 BLUE 100 PCS FDA UDI
Ear Tip ET-11 Pack/100 pcs. FDA UDI
Generic Name
Evoked-potential audiometer FDA UDI
Device Name
Ear Tips for Ear Probes EUDAMED
Model / Reference
100125-100 EUDAMEDFDA UDI
100125-50 FDA UDI
8-68-34507 FDA UDI

Identifiers

Primary DI / UDI-DI
04260223145346 EUDAMEDFDA UDI
04260223141867 FDA UDI
04260223141843 FDA UDI
Basic UDI-DI
0426022Probes-16B EUDAMED
FDA Product Code
GWJ FDA UDI
ETT FDA UDI
EMDN Code
Z12140380,Z12149001 EUDAMED
GMDN Term
Evoked-potential audiometer FDA UDI

Classification

Device Class
Class I EUDAMED
Class II FDA UDI
Regulation Number
882.1900 FDA UDI
874.1100 FDA UDI
Market of Registration
Germany EUDAMED
Commercial Distribution
Not in Commercial Distribution FDA UDI
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

Yes

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

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Ear Tip ET-11 Pack/50 pcs. by PATH medical GmbH — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
PATH medical GmbH

Sources (4)

  • FDA UDI fb8e4bc7-d7d9-4fff-ab40-943dca606f85 33 fields · synced Jul 13, 2026
  • FDA UDI 4bb5ab9a-311c-4d19-b0e0-4fbb1a102082 32 fields · synced May 30, 2026
  • FDA UDI 27e9da34-cd7b-4120-86c9-5def17eade4c 32 fields · synced May 30, 2026
  • EUDAMED 4f6eee78-a696-46ea-8a9d-685714172fab 61 fields · synced Jul 13, 2026