Peak flow meter – Low range 50-300 L/min
EUDAMEDFDA UDIClass IIa (EU MDR)
Identity
- Trade Name
- Peak flow meter-low range 50-300 L/min EUDAMEDCHILD PEAKFLOW METER FDA UDI
- Generic Name
- Peak flow meter, manual FDA UDI
- Device Name
- Peak flow meter – Low range 50-300 L/min EUDAMEDPeak flow meter-standard range 50-800 L/min EUDAMEDCHILD PEAKFLOW METER FDA UDI
- Model / Reference
- PF-29200 EUDAMEDFDA UDIPF-29100 EUDAMED
- Description
- CHILD PEAKFLOW METER FDA UDI
Identifiers
- Primary DI / UDI-DI
- D-PF-29200YQ EUDAMED04716770292007 EUDAMEDFDA UDI
- Basic UDI-DI
- B-PF-29200YQ EUDAMED4716770PF02900G7 EUDAMED
- Direct Marketing DI
- 04716770292007 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 IIa EUDAMEDClass I EUDAMEDClass II FDA UDI
- Regulation Number
- 868.1860 FDA UDI
- Market of Registration
- Germany EUDAMEDCyprus EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
Yes
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Expiratory peak flow meter, digital
Peak flow meter – Low range 50-300 L/min by Besmed Health Business Corp. — Class IIa — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID
Similar devices
Also classified as Expiratory peak flow meter, digital.
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- Model 4000 — Vitalograph Ireland, Ltd. · Class II
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
CE/MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-PF-29200YQ | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-PF-29200YQ | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Besmed Health Business Corp.
- EUDAMED SRN
- TW-MF-000007246
- Authorised Representative
- Casus Europe B.V. NL-AR-000037688
Sources (3)
- EUDAMED 19cc81c1-7f01-457f-b9d6-030eeac499a8 61 fields · synced Jul 11, 2026
- EUDAMED e8575ddd-23da-4be4-8a0a-68b1e3eb962e 61 fields · synced May 19, 2026
- FDA UDI 32d2ec3c-1e4b-4fa8-b404-c892cea48522 34 fields · synced May 24, 2026