Identity
- Device Name
- Test Chamber (2 PCS) EUDAMED
- Model / Reference
- 116001 EUDAMED116002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08059308000818 EUDAMED
- Basic UDI-DI
- 8059308SUR_ACC_009JP EUDAMED
- EMDN Code
- A060399 FLUID COLLECTION BAGS AND SYSTEMS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
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
Category: General-purpose suction system, pneumatic
Test Chamber (2 PCS) by Optikon 2000 S.p.A. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as General-purpose suction system, pneumatic.
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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 | 8059308SUR_ACC_009JP | Class I | Active |
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Manufacturer
- Manufacturer
- Optikon 2000 S.p.A.
- EUDAMED SRN
- IT-MF-000017618
Sources (1)
- EUDAMED de47eb5e-0e40-41ca-a683-13db7e7bc7e4 61 fields · synced Jun 18, 2026