Identity
- Trade Name
- HeartPrint FDA UDI
- Generic Name
- Custom-made organ/bone anatomy model FDA UDI
- Device Name
- Heartprint medical model, SLA FDA UDI
- Model / Reference
- HEAPR-01-002-01 FDA UDI
- Description
- Heartprint medical model, SLA FDA UDI
Identifiers
- Catalog Number
- HEAPR-01-002-01 FDA UDI
- Primary DI / UDI-DI
- 05420060346002 FDA UDI
- 510(k) Number
- K183105 FDA UDI
- FDA Product Code
- LLZ FDA UDI
- GMDN Term
- Custom-made organ/bone anatomy model FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Custom-made organ/bone anatomy model
HeartPrint by Materialise NV — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K183105 also covers:
- HeartPrint — Materialise NV
- Mimics — Materialise NV
- Mimics — Materialise NV
- Mimics — Materialise NV
- Mimics — Materialise NV
- Mimics — Materialise NV
- Mimics — Materialise NV
- Mimics — Materialise NV
- Mimics — Materialise NV
- Mimics — Materialise NV
- Mimics — Materialise NV
- Mimics Automatic Algorithms — Materialise NV
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Materialise NV
Sources (1)
- FDA UDI ce7dc2aa-8f5e-46a3-a024-57c1dbc91520 35 fields · synced May 30, 2026