Mir

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref 911028 - 911028T - 911028E0 - 911028E1 - 911028I0 - 911028I1Model MIR059

by Mir Medical International Research

Identity

Trade Name: Spirobank II with Bluetooth Smart EUDAMED
MIR FDA UDI
Generic Name: Expiratory peak flow meter, digital FDA UDI
Device Name: Portable spirometer for lung function testing with Bluetooth smart technology FDA UDI
Model / Reference: MIR059 EUDAMED
911028 - 911028T - 911028E0 - 911028E1 - 911028I0 - 911028I1 EUDAMED
MIR Spirobank II New BLE spirometer FDA UDI
Description: Portable spirometer for lung function testing with Bluetooth smart technology FDA UDI

Identifiers

Primary DI / UDI-DI: 08052990320905 EUDAMEDFDA UDI
Basic UDI-DI: 805299032056-059EU EUDAMED
510(k) Number: K061712 FDA UDI
FDA Product Code: BZG FDA UDI
EMDN Code: Z12150102 PEAK FLOW SPIROMETERS EUDAMED
GMDN Term: Expiratory peak flow meter, digital FDA UDI

Classification

Device Class: Class IIa EUDAMED
Class II FDA UDI
Regulation Number: 868.1840 FDA UDI
Market of Registration: Italy EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

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

FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Expiratory peak flow meter, digital

Mir by Mir Medical International Research — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Expiratory peak flow meter, digital.

Model 4000 — Vitalograph Ireland, Ltd. · Class II
Spirolab — MIR - Medical International Research S.p.A. · Class IIa
Spirolab Plus — MIR - Medical International Research S.p.A. · Class IIa
NxGen Peak Flow Meter — SAFEY MEDICAL DEVICES PRIVATE LIMITED · Class II
Spirosound — Medset Medizintechnik GmbH · Class IIa
Model 4000 — Vitalograph Ireland, Ltd. · Class II
Model 4000 — Vitalograph Ireland, Ltd. · Class II
Model 4000 — Vitalograph Ireland, Ltd. · Class II

Cleared under the same submission

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class II	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Mir Medical International Research

Sources (2)

FDA UDI 6972ad1d-a8d0-4291-830b-e369d2daf444 34 fields · synced Jul 15, 2026
EUDAMED 2e60438c-7235-4744-844a-1c4fee952f80 61 fields · synced Jul 15, 2026