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LAP-L Longitudinal Arch Support Plain
EUDAMEDClass I (EU MDR)
Ref 71353 Model Large
Identity
- Trade Name
- LAP-L Longitudinal Arch Support Plain EUDAMED
- Device Name
- Soft Stride™ LAP-L Longitudinal Arch Support Plain EUDAMED
- Model / Reference
- Large EUDAMED71353 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00821617135318 EUDAMED
- Basic UDI-DI
- 082161SSLASPLG713SV EUDAMED
- EMDN Code
- Y061203 ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS) 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
Category: Orthotic insole, prefabricated, non-antimicrobial
LAP-L Longitudinal Arch Support Plain by Brownmed, Inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Orthotic insole, prefabricated, non-antimicrobial.
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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 | 082161SSLASPLG713SV | Class I | Active |
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Manufacturer
- Manufacturer
- Brownmed, Inc.
- EUDAMED SRN
- US-MF-000008271
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (1)
- EUDAMED aee3cde6-1662-4f23-bca6-ef26408a8aee 61 fields · synced Jul 25, 2026