Identity
- Trade Name
- PROACCESS (R) EUDAMED
- Device Name
- Introducer Sheath EUDAMED
- Model / Reference
- 111703R EUDAMED111706R EUDAMED111705R EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08906026863051 EUDAMED08906026863082 EUDAMED08906026863075 EUDAMED
- Basic UDI-DI
- 890602686RISRQ EUDAMED
- Direct Marketing DI
- 08906026863051 EUDAMED08906026863082 EUDAMED08906026863075 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 (r) 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 | 890602686RISRQ | 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 (3)
- EUDAMED 6b2ec6e3-bfca-417d-8971-98980fa0cb46 61 fields · synced Jul 30, 2026
- EUDAMED 8a6bdc98-df35-4eda-b6e0-1426b1d413ea 61 fields · synced May 17, 2026
- EUDAMED 1bd6d41a-6db5-43f5-997c-b0a2b6c1f1ea 61 fields · synced May 18, 2026