Identity
- Trade Name
- IBPM Stopcock 1-Way w/5cm PE Line Clear EUDAMED
- Device Name
- Pressure Monitoring Line EUDAMED
- Model / Reference
- 21BB/303 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09555240403094 EUDAMED
- Basic UDI-DI
- B-09555240403094 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
IBPM Stopcock 1-Way w/5cm PE Line Clear 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-09555240403094 | 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 94bdd55c-4744-433d-88e6-d52da683ac4a 61 fields · synced Jun 20, 2026