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Mullins-X
EUDAMEDFDA 510(k)Class III (EU MDR)
Ref PTM451Model 250.1XRef PTM456Ref PTM443Ref PTM445Ref PTM440510(k) K041093Ref PTM453Ref PTM457Ref PTM455
by NuMED, Inc.
Identity
- Trade Name
- Mullins-X EUDAMED
- Device Name
- Mullins-X EUDAMED
- Model / Reference
- 250.1X EUDAMEDPTM451 EUDAMEDPTM456 EUDAMEDPTM443 EUDAMEDPTM445 EUDAMEDPTM440 EUDAMEDPTM453 EUDAMEDPTM457 EUDAMEDPTM455 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10887714000482 EUDAMED10887714000543 EUDAMED10887714000321 EUDAMED10887714000369 EUDAMED10887714000260 EUDAMED10887714000529 EUDAMED10887714000567 EUDAMED10887714000604 EUDAMED
- Basic UDI-DI
- B-10887714000482 EUDAMEDB-10887714000543 EUDAMEDB-10887714000321 EUDAMEDB-10887714000369 EUDAMEDB-10887714000260 EUDAMEDB-10887714000529 EUDAMEDB-10887714000567 EUDAMEDB-10887714000604 EUDAMED
- 510(k) Number
- K041093 FDA 510(k)
- FDA Product Code
- DQY FDA 510(k)
- EMDN Code
- C019014 CARDIAC VALVULOPLASTY CATHETERS EUDAMED
Classification
- Device Class
- Class III EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1250 FDA 510(k)
- Regulation Number
- 870.1250 FDA 510(k)
- Market of Registration
- Belgium EUDAMED
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
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
Mullins-X by NuMED, Inc. — Class III — 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 | K041093 | Class III | Active |
| EUDAMED | European Union | CE/MDD | B-10887714000482 | Class III | Active |
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Manufacturer
- Manufacturer
- NuMED, Inc.
- EUDAMED SRN
- US-MF-000010948
- Authorised Representative
- EVOMED S.L.U. ES-AR-000047116
Sources (9)
- EUDAMED 8733978e-353f-47b8-b59e-a60444295bb8 61 fields · synced Aug 3, 2026
- EUDAMED 9f43e568-3272-4b99-9ec4-db875fa21478 61 fields · synced May 17, 2026
- EUDAMED 3c525db0-1db3-49ce-9e05-19eb0ccf1f49 61 fields · synced May 17, 2026
- EUDAMED 5767449f-34ea-4e22-87c1-9d25e5f2c0fa 61 fields · synced May 17, 2026
- EUDAMED 2846220c-295b-4301-a23d-db819b82de42 61 fields · synced May 18, 2026
- FDA 510(k) K041093 24 fields · synced May 18, 2026
- EUDAMED db0262f2-ba24-43e9-86ca-03733929b56a 61 fields · synced Jul 26, 2026
- EUDAMED eddfb2cb-d320-44a1-8271-45dbab2a39b4 61 fields · synced Aug 2, 2026
- EUDAMED 8ff7039f-c584-482d-abf0-25709ae0550f 61 fields · synced Aug 3, 2026