Identity
- Trade Name
- 15CM RED LINE W/3 WAY STOPCOCK EUDAMED
- Device Name
- Pressure Monitoring Line EUDAMED
- Model / Reference
- 21BB/PVB-080-115R EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09555240403193 EUDAMED
- Basic UDI-DI
- B-09555240403193 EUDAMED
- EMDN Code
- Z12030285 VITAL SIGNS MONITORING INSTRUMENTS - CONSUMABLES 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
15cm Red Line W/3 Way Stopcock by Itl Asia Pacific Sdn. Bhd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-09555240403193 | Class IIa | Active |
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Manufacturer
- Manufacturer
- ITL Asia Pacific Sdn. Bhd.
- EUDAMED SRN
- MY-MF-000001570
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED a1bf2f20-39d3-4d53-8b29-17f6ae2854ac 61 fields · synced Jun 20, 2026