Identity
- Trade Name
- PROACCESS EUDAMED
- Device Name
- Introducer Sheath EUDAMED
- Model / Reference
- 111107 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08906026860463 EUDAMED
- Basic UDI-DI
- 890602686FISPU EUDAMED
- Direct Marketing DI
- 08906026860463 EUDAMED
- EMDN Code
- C058001 ADAPTERS AND CONNECTORS FOR CARDIOVASCULAR INTRODUCERS EUDAMED
Classification
- Device Class
- Class IIa 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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Proaccess by Invent Bio-Med Pvt Ltd — Class IIa — 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 | 890602686FISPU | Class IIa | Active |
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Manufacturer
- Manufacturer
- Invent Bio-Med Pvt Ltd
- EUDAMED SRN
- IN-MF-000028640
- Authorised Representative
- mdi Europa GmbH DE-AR-000006218
Sources (1)
- EUDAMED 0b70f757-92fc-4566-9f6d-4eb9864365e5 61 fields · synced Jun 18, 2026