Identity
- Trade Name
- Intro EUDAMED
- Device Name
- Intro EUDAMED
- Model / Reference
- PT16100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08057276004432 EUDAMED
- Basic UDI-DI
- B-08057276004432 EUDAMED
- EMDN Code
- A018003 NEEDLE INTRODUCERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Intro by M.d.l. S.r.l. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08057276004432 | Class IIa | Active |
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Manufacturer
- Manufacturer
- M.D.L. S.r.l.
- EUDAMED SRN
- IT-MF-000011599
Sources (1)
- EUDAMED eb357244-caf3-4b1c-8156-d309fb475295 61 fields · synced May 22, 2026