EasyOne Diagnostic Spirometer

FDA UDI

Class II (US FDA UDI)

by NDD Medizintechnik AG

Identity

Trade Name: EasyOne Diagnostic Spirometer FDA UDI
Generic Name: Diagnostic spirometer, professional FDA UDI
Model / Reference: 2001-2 FDA UDI

Identifiers

Catalog Number: 2001-2 FDA UDI
Primary DI / UDI-DI: 07640142190059 FDA UDI
510(k) Number: K993921 FDA UDI
FDA Product Code: BZG FDA UDI
GMDN Term: Diagnostic spirometer, professional FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.1840 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Diagnostic spirometer, professional

EasyOne Diagnostic Spirometer by NDD Medizintechnik AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K993921 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: NDD Medizintechnik AG

Sources (1)

FDA UDI 81c52487-5800-4ec9-8c11-c5d52e7e4df7 36 fields · synced May 30, 2026