Identity
- Trade Name
- TRI FLO ADAPTOR STANDARD EUDAMED
- Device Name
- Pressure Monitoring Line EUDAMED
- Model / Reference
- 21BB/LM100-3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09555240405579 EUDAMED
- Basic UDI-DI
- B-09555240405579 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
Tri Flo Adaptor Standard 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-09555240405579 | 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 c5026422-73d6-4408-a888-ba336bdd4fa7 61 fields · synced Jun 17, 2026