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I/A kit for Pulsar: ACS3, tubing and drainage bag
EUDAMEDClass IIa (EU MDR)
Ref 191702
Identity
- Trade Name
- I/A kit for Pulsar: ACS3, tubing and drainage bag EUDAMED
- Device Name
- I/A kit for Pulsar: ACS3, tubing and drainage bag EUDAMED
- Model / Reference
- 191702 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08059308008883 EUDAMED
- Basic UDI-DI
- 8059308SUR_INF_007UB EUDAMED
- EMDN Code
- A070102 IRRIGATION TUBING ADAPTERS AND CONNECTORS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy 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
I/A kit for Pulsar: ACS3, tubing and drainage bag by Optikon 2000 S.p.A. — 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 | 8059308SUR_INF_007UB | Class IIa | Active |
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Manufacturer
- Manufacturer
- Optikon 2000 S.p.A.
- EUDAMED SRN
- IT-MF-000017618
Sources (1)
- EUDAMED fa743fad-9abe-48b7-83d8-6031ee9efd50 61 fields · synced Jul 24, 2026