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Edda Technology

FDA UDI

Class II (US FDA UDI)

by EDDA Technology, Inc.

Identity

Trade Name
EDDA TECHNOLOGY FDA UDI
Generic Name
Electromagnetic surgical navigation device tracking system FDA UDI
Device Name
IQQA-Guide is intended for intra-operative guidance for surgical procedures FDA UDI
Model / Reference
IQQA-Guide FDA UDI
Description
IQQA-Guide is intended for intra-operative guidance for surgical procedures FDA UDI

Identifiers

Primary DI / UDI-DI
00868466000237 FDA UDI
510(k) Number
K151414 FDA UDI
FDA Product Code
JAK FDA UDI
GMDN Term
Electromagnetic surgical navigation device tracking system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1750 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

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
MRI Safety
MR Unsafe FDA UDI

Category: Electromagnetic surgical navigation device tracking system

Edda Technology by EDDA Technology, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electromagnetic surgical navigation device tracking system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
EDDA Technology, Inc.

Sources (1)

  • FDA UDI 5f71ecfc-449d-4198-b0fc-bebd3b3e11bb 36 fields · synced Jun 8, 2026