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lifesense
EUDAMEDClass I (EU MDR)
Ref MD1011Model DL-F03、DL-F04Ref MD1012Model DL-YZ01、DL-YZ08、DL-YZ09、DL-YZ15、DL-YZ16、DL-YZ19、DL-YZ20
Identity
- Trade Name
- lifesense EUDAMED
- Device Name
- Peak Flow Meters EUDAMEDMedical Mouthpieces EUDAMED
- Model / Reference
- DL-F03、DL-F04 EUDAMEDMD1011 EUDAMEDDL-YZ01、DL-YZ08、DL-YZ09、DL-YZ15、DL-YZ16、DL-YZ19、DL-YZ20 EUDAMEDMD1012 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970701961921 EUDAMED06970701961938 EUDAMED
- Basic UDI-DI
- 697070196460031001NE EUDAMED697070196420131001LF EUDAMED
- EMDN Code
- Z12150102 PEAK FLOW SPIROMETERS EUDAMEDR9001 RESPIRATORY MOUTHPIECES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland 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
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Expiratory peak flow meter, digital
lifesense by Taian Dalu Medical Instrument 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 | 697070196460031001NE | Class I | Active |
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Manufacturer
- Manufacturer
- Taian Dalu Medical Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000003009
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED 630329a1-6f1c-49a2-819b-6f68ed0df611 61 fields · synced Jul 9, 2026
- EUDAMED eaf8f8f7-fa2f-414c-8383-d4f310858bd2 61 fields · synced May 18, 2026