Identity
- Trade Name
- Night Splint EUDAMED
- Device Name
- Night Splint EUDAMED
- Model / Reference
- S,M,L,XL,Universal EUDAMEDL EUDAMEDS EUDAMEDM EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06979025030498 EUDAMED06979025030474 EUDAMED06979025030481 EUDAMED
- Basic UDI-DI
- 697902503NTSUH EUDAMED
- EMDN Code
- Y061203 ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Night Splint by Xiamen Bosegrow Medical Equipment Co., Ltd — 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 | 697902503NTSUH | Class I | Active |
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Manufacturer
- Manufacturer
- Xiamen Bosegrow Medical Equipment Co., Ltd
- EUDAMED SRN
- CN-MF-000048932
- Authorised Representative
- HyperCert Limited B.V. NL-AR-000047746
Sources (3)
- EUDAMED 8e7f59c4-bb03-4ba8-92ea-74ee146f374f 61 fields · synced Oct 6, 2026
- EUDAMED 9ea9c498-4b8e-4506-9ce3-701727844bd0 61 fields · synced May 16, 2026
- EUDAMED 6856e9df-dcb5-48b0-a08d-bd7363f70ec2 61 fields · synced May 17, 2026