Identity
- Trade Name
- Balboa Comfort LSO Brace, Large EUDAMED
- Device Name
- Orthoses EUDAMED
- Model / Reference
- LS-627B-L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809689808615 EUDAMED
- Basic UDI-DI
- 880968980STNGORTHOWV EUDAMED
- EMDN Code
- Y060308 LUMBOSACRAL SPINE ORTHOSES 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
Balboa Comfort LSO Brace, Large by ST&G Corporation — 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 | 880968980STNGORTHOWV | Class I | Active |
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Manufacturer
- Manufacturer
- ST&G Corporation
- EUDAMED SRN
- KR-MF-000010453
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED 87ce1103-422a-47cc-80ad-fa22a82477cc 61 fields · synced Sep 17, 2026