Identity
- Trade Name
- APTĒ EUDAMED
- Device Name
- APTĒ EUDAMED
- Model / Reference
- APS EUDAMEDSKA100100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08052204714162 EUDAMED
- Basic UDI-DI
- 80522047103SKAQR EUDAMED
- EMDN Code
- A05010101 ELASTOMERIC SYSTEMS - FIXED FLOW W/O ADDITIONAL BOLUS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Aptē by Adria Med S.r.l. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 80522047103SKAQR | Class IIb | Active |
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Manufacturer
- Manufacturer
- Adria Med S.r.l.
- EUDAMED SRN
- IT-MF-000020866
Sources (1)
- EUDAMED a76910cc-3d2a-4cf1-a63c-3e638262ea09 61 fields · synced Jun 19, 2026