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Bioptimal Angiographic Kit
EUDAMEDClass IIa (EU MDR)
Ref 22-000217-06Model 3-GMF ,RH (OFF)-500 PSI
Identity
- Trade Name
- Bioptimal Angiographic Kit EUDAMED
- Device Name
- Angiographic Kit EUDAMED
- Model / Reference
- 3-GMF ,RH (OFF)-500 PSI EUDAMED22-000217-06 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08886483502055 EUDAMED
- Basic UDI-DI
- B-08886483502055 EUDAMED
- EMDN Code
- C010480 ANGIOGRAPHY AND HEMODYNAMICS DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Croatia 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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Vascular guidewire introduction sleeve
Bioptimal Angiographic Kit by Bioptimal International Pte. Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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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-08886483502055 | 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 2b00c535-f827-4ce3-9dd7-558592068ee8 61 fields · synced Jun 17, 2026