Identity
- Trade Name
- SPIRO LENIS EUDAMED
- Device Name
- SPIRO LENIS EUDAMED
- Model / Reference
- SL503 EUDAMEDPRD-LS-001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800184100006 EUDAMED
- Basic UDI-DI
- B-08800184100006 EUDAMED8800184SPIRO54 EUDAMED
- EMDN Code
- Z12150101 CLINICAL/DIAGNOSTIC SPIROMETERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Denmark 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
Spiro Lenis by Jnbio — Class IIa — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-08800184100006 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-08800184100006 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Jnbio
- EUDAMED SRN
- KR-MF-000042575
- Authorised Representative
- Javitech Consulting GmbH DE-AR-000045915
Sources (2)
- EUDAMED d21a5d3a-ee37-49fd-a8de-2f4bf204b973 61 fields · synced Jul 29, 2026
- EUDAMED d5c2ae05-3a41-4c8d-909c-e9f6f0eb5b96 61 fields · synced May 17, 2026