Identity
- Trade Name
- Hero EUDAMED
- Device Name
- Easy Squeezy EUDAMED
- Model / Reference
- ES-9502000-BAF EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06009900675602 EUDAMED
- Basic UDI-DI
- 60099006756ES4A EUDAMED
- EMDN Code
- R9099 RESPIRATORY AND ANAESTHESIA DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Belgium 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: Pulmonary function analysis system, adult
Hero by Impulse Biomedical (Pty) Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 60099006756ES4A | Class I | Active |
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Manufacturer
- Manufacturer
- Impulse Biomedical (Pty) Ltd
- EUDAMED SRN
- ZA-MF-000045961
- Authorised Representative
- Easy Medical Device BE-AR-000011902
Sources (1)
- EUDAMED 28bbb107-6312-4e31-909b-a0fe074a1595 61 fields · synced Jun 19, 2026