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Accutrans
EUDAMEDClass IIa (EU MDR)
Ref 22-000948-32Model AT 6012-3 (AT 6012-3B)
Identity
- Trade Name
- Accutrans EUDAMED
- Device Name
- Pressure Monitoring Systems and Kits, Accutrans EUDAMED
- Model / Reference
- AT 6012-3 (AT 6012-3B) EUDAMED22-000948-32 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08886483508934 EUDAMED
- Basic UDI-DI
- B-08886483508934 EUDAMED
- EMDN Code
- Z1203020302 NON–INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Czechia 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-08886483508934 | 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 (1)
- EUDAMED e4c013a9-b2cf-4f50-b41f-2d6de757ef46 61 fields · synced May 29, 2026