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UltraPrint Hard Splint Try-in UV
EUDAMEDClass I (EU MDR)
Ref MA.004.661Model Hard Splint Try-in UV Transparent
Identity
- Trade Name
- UltraPrint Hard Splint Try-in UV EUDAMED
- Model / Reference
- Hard Splint Try-in UV Transparent EUDAMEDMA.004.661 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971437944349 EUDAMED
- Basic UDI-DI
- 697143794HSTRYINDQ EUDAMED
- EMDN Code
- Q0102050199,Q010699 EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
UltraPrint Hard Splint Try-in UV by Guangzhou Heygears Imc.inc — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Unknown
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697143794HSTRYINDQ | Class I | Unknown |
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Manufacturer
- Manufacturer
- Guangzhou Heygears Imc.inc
- EUDAMED SRN
- CN-MF-000010624
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED c38b31a6-4b63-4331-8e18-5f3baf037ae6 61 fields · synced Jun 18, 2026