Identity
- Trade Name
- MRCP+ EUDAMED
- Device Name
- MRCP+ EUDAMED
- Model / Reference
- v1.01 EUDAMED1.01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +B554MRCP10 EUDAMED
- Basic UDI-DI
- B-+B554MRCP10 EUDAMED
- 510(k) Number
- K183133 FDA 510(k)
- FDA Product Code
- LLZ FDA 510(k)
- EMDN Code
- Z11059082 VARIOUS MAGNETIC RESONANCE IMAGING INSTRUMENTS - SOFTWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.2050 FDA 510(k)
- Regulation Number
- 892.2050 FDA 510(k)
- Special Device Type
- -1192 EUDAMED
- Market of Registration
- Portugal EUDAMED
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
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
Mrcp+ by Perspectum, Ltd. — Class I — FDA_510K, MDD — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K183133 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-+B554MRCP10 | Class I | Active |
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Manufacturer
- Manufacturer
- Perspectum Ltd
- EUDAMED SRN
- GB-MF-000016685
- Authorised Representative
- Perspectum Unipessoal Lda PT-AR-000009160
Sources (2)
- EUDAMED 7d28baa9-0ccd-48f2-97c9-821806517881 61 fields · synced Jul 16, 2026
- FDA 510(k) K183133 24 fields · synced May 18, 2026