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Peak Scoliosis Bracing System, Dual Strut Configuration Kit
EUDAMEDClass I (EU MDR)
Ref 993905
Identity
- Trade Name
- PEAK SCOLIOSIS BRACING SYSTEM, DUAL STRUT CONFIGURATION KIT EUDAMED
- Device Name
- SCOLI EUDAMED
- Model / Reference
- 993905 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00818249013268 EUDAMED
- Basic UDI-DI
- 081824901SCOLIAL EUDAMED
- EMDN Code
- Y060306 THORACOLUMBAR ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
Peak Scoliosis Bracing System, Dual Strut Configuration Kit by Aspen Medical Products, LLC — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 081824901SCOLIAL | Class I | Active |
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Manufacturer
- Manufacturer
- Aspen Medical Products, LLC
- EUDAMED SRN
- US-MF-000001571
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 874dccd9-90da-45fb-ab78-3a592ebcc8e6 61 fields · synced Oct 6, 2026