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Microlife
EUDAMEDClass I (EU MDR)
Ref PF-10Model PF-10(BR-PEF231)Ref NEB210/p957210-3Model BR-CN116
Identity
- Trade Name
- Microlife EUDAMED
- Device Name
- Peak Flow Meter EUDAMEDCompressor nebulizer EUDAMED
- Model / Reference
- PF-10(BR-PEF231) EUDAMEDPF-10 EUDAMEDBR-CN116 EUDAMEDNEB210/p957210-3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975070910310 EUDAMED06975070916008 EUDAMED
- Basic UDI-DI
- 697507091PFMTJ EUDAMED697507091CNZN EUDAMED
- Direct Marketing DI
- 06975070910310 EUDAMED
- EMDN Code
- Z12150102 PEAK FLOW SPIROMETERS EUDAMEDR060101 COLD NEBULISATION SYSTEMS EUDAMED
Classification
- Device Class
- Class I EUDAMEDClass IIa EUDAMED
- Market of Registration
- Poland EUDAMEDItaly EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMEDEUDAMED
Measuring Function
Yes
EUDAMEDEUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Expiratory peak flow meter, digital
Microlife by ShenZhen Bi-rich Medical Devices Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Expiratory peak flow meter, digital.
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- 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 (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697507091PFMTJ | Class I | Active |
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Manufacturer
- Manufacturer
- ShenZhen Bi-rich Medical Devices Co., Ltd
- EUDAMED SRN
- CN-MF-000023061
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED dfa1a693-d33f-4fa4-b859-33181987c542 61 fields · synced Sep 18, 2026
- EUDAMED 7cff1f0c-d26f-4e78-a5a6-5055e63e83fc 61 fields · synced May 18, 2026