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Proaccess
EUDAMEDClass IIa (EU MDR)
Ref 111109Ref 111110Ref 111111Ref 111106Ref 111108
Identity
- Trade Name
- PROACCESS EUDAMED
- Device Name
- Introducer Sheath EUDAMED
- Model / Reference
- 111109 EUDAMED111110 EUDAMED111111 EUDAMED111106 EUDAMED111108 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08906026860487 EUDAMED08906026860494 EUDAMED08906026860500 EUDAMED08906026860456 EUDAMED08906026860470 EUDAMED
- Basic UDI-DI
- 890602686FISPU EUDAMED
- Direct Marketing DI
- 08906026860487 EUDAMED08906026860494 EUDAMED08906026860500 EUDAMED08906026860456 EUDAMED08906026860470 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 (5)
- EUDAMED 5935ab73-d26f-43b4-ac24-87a09294fdaf 61 fields · synced Jul 19, 2026
- EUDAMED a4295c9f-c3d6-48cc-bde3-9acb5db7ac80 61 fields · synced May 17, 2026
- EUDAMED fe7199c1-0b70-48df-824f-a89c58b41062 61 fields · synced May 18, 2026
- EUDAMED 8477e24d-8f8a-48a3-9336-f03a3367c558 61 fields · synced May 18, 2026
- EUDAMED 602ad6a9-f3e7-47a5-afa5-e6e71fc31ada 61 fields · synced May 19, 2026