Peak flow meter-standard range 50-800 L/min

EUDAMEDFDA UDIFDA 510(k)

Class I (EU MDR)

Ref PF-29100510(k) K172804

by Besmed Health Business Corp.

Identity

Trade Name: Peak flow meter-standard range 50-800 L/min EUDAMED
ADULT PEAKFLOW METER FDA UDI
Generic Name: Peak flow meter, manual FDA UDI
Device Name: Peak flow meter-standard range 50-800 L/min EUDAMED
ADULT PEAKFLOW METER FDA UDI
Model / Reference: PF-29100 EUDAMEDFDA UDI
Description: ADULT PEAKFLOW METER FDA UDI

Identifiers

Primary DI / UDI-DI: 04716770291000 EUDAMEDFDA UDI
Basic UDI-DI: 4716770PF02900G7 EUDAMED
Direct Marketing DI: 04716770291000 EUDAMED
510(k) Number: K172804 FDA UDI
FDA Product Code: BZH FDA UDI
EMDN Code: Z12150102 PEAK FLOW SPIROMETERS EUDAMED
GMDN Term: Peak flow meter, manual FDA UDI

Classification

Device Class: Class I EUDAMED
Class II FDA UDI
Regulation Number: 868.1860 FDA UDI
Market of Registration: Bulgaria 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

Yes

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

Yes

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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Expiratory peak flow meter, digital

Peak flow meter-standard range 50-800 L/min by Besmed Health Business Corp. — Class I — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k)

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

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDR

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K172804	Class I	Active
EUDAMED	European Union	CE/MDR	4716770PF02900G7	Class I	Active

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Besmed Health Business Corp.
EUDAMED SRN: TW-MF-000007246
FDA Applicant: Besmed Health Business Corp
Authorised Representative: Casus Europe B.V. NL-AR-000037688

Sources (4)

EUDAMED 459a4676-53be-461f-b511-f3027ddef4d6 85 fields · synced Jun 19, 2026
FDA UDI 8bc7d9a9-fe81-40f3-a2e4-ab9bdcdcfbcf 34 fields · synced May 27, 2026
EUDAMED 963cb511-6339-478d-a9f8-c0a7b986ac5d 61 fields · synced Jun 19, 2026
FDA 510(k) K172804 1 fields · synced May 18, 2026