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Accutrans
EUDAMEDClass IIa (EU MDR)
Ref 22-000948-22Model AT2 4812-3RB (IM2 4812-3RB)Ref 22-000948-16Model AT 4812-3R Ref 22-000948-34Model AT BC-248A (EUROPE-CAT# AT 248-A MV)Ref 22-000948-47Model AT3 4812-3(CROATIA)Ref 22-000948-33Model AT 6012-3 (AT 6012-3R) Ref 22-000948-46Model AT2 4812-3(CROATIA)Ref 22-000948-45Model AT 4812-3(CROATIA)
Identity
- Trade Name
- Accutrans EUDAMED
- Device Name
- Pressure Monitoring Systems and Kits, Accutrans EUDAMED
- Model / Reference
- AT2 4812-3RB (IM2 4812-3RB) EUDAMED22-000948-22 EUDAMEDAT 4812-3R EUDAMED22-000948-16 EUDAMEDAT BC-248A (EUROPE-CAT# AT 248-A MV) EUDAMED22-000948-34 EUDAMEDAT3 4812-3(CROATIA) EUDAMED22-000948-47 EUDAMEDAT 6012-3 (AT 6012-3R) EUDAMED22-000948-33 EUDAMEDAT2 4812-3(CROATIA) EUDAMED22-000948-46 EUDAMEDAT 4812-3(CROATIA) EUDAMED22-000948-45 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08886483504264 EUDAMED08886483504202 EUDAMED08886483509382 EUDAMED08886483512535 EUDAMED08886483508941 EUDAMED08886483512528 EUDAMED08886483512511 EUDAMED
- Basic UDI-DI
- B-08886483504264 EUDAMEDB-08886483504202 EUDAMEDB-08886483509382 EUDAMEDB-08886483512535 EUDAMEDB-08886483508941 EUDAMEDB-08886483512528 EUDAMEDB-08886483512511 EUDAMED
- EMDN Code
- Z1203020302 NON–INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Greece EUDAMEDGermany EUDAMEDCzechia 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
Accutrans by Bioptimal International Pte. Ltd. — 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-08886483504264 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Bioptimal International PTE. LTD.
- EUDAMED SRN
- SG-MF-000010306
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (7)
- EUDAMED 65608dbb-b413-4c72-84aa-f49d198f2a1a 61 fields · synced Sep 30, 2026
- EUDAMED 1659c61a-b21e-4dae-bbf7-f6cb8f5f61fe 61 fields · synced May 11, 2026
- EUDAMED d0165989-4dc2-4d12-868d-c7833d439c42 61 fields · synced May 17, 2026
- EUDAMED b27884df-d389-425b-ac8e-84b33efb880d 61 fields · synced May 18, 2026
- EUDAMED aa891479-10c1-4f0d-8808-b87605181bfa 61 fields · synced May 18, 2026
- EUDAMED 50ac8a44-a821-4768-9f67-dea6053c7823 61 fields · synced May 18, 2026
- EUDAMED a81d9d4a-6f01-4024-b37d-7c12bd8331b4 61 fields · synced May 18, 2026