Identity
- Device Name
- Peak Flow Meter EUDAMED
- Model / Reference
- EP-70102, EP-70103 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972366680766 EUDAMED
- Basic UDI-DI
- 6972366SHEP-1010BZ EUDAMED
- Direct Marketing DI
- 06972366680766 EUDAMED
- EMDN Code
- Z12150102 PEAK FLOW SPIROMETERS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Expiratory peak flow meter, digital
Peak Flow Meter by Shanghai Everpure Medical Plastic Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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- 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 | 6972366SHEP-1010BZ | Class I | Active |
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Manufacturer
- Manufacturer
- Shanghai Everpure Medical Plastic Co., Ltd.
- EUDAMED SRN
- CN-MF-000013448
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (2)
- EUDAMED d8c63a9b-1c6f-4b69-8c19-f332919bffd8 61 fields · synced Jun 19, 2026
- EUDAMED d8c63a9b-1c6f-4b69-8c19-f332919bffd8-1 61 fields · synced Jun 9, 2026