Identity
- Trade Name
- Surestep EUDAMED
- Device Name
- SureStep Big Shot AFO Lite EUDAMED
- Model / Reference
- 1907-BSL-SS-2280 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810080701076 EUDAMED
- Basic UDI-DI
- 00810080701907-BSL-SSLQ EUDAMED
- Direct Marketing DI
- 00810080701076 EUDAMED
- EMDN Code
- Y06120601 PASSIVE ANKLE-FOOT 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
Surestep by Surestep, 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 | 00810080701907-BSL-SSLQ | Class I | Active |
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Manufacturer
- Manufacturer
- Surestep, LLC
- EUDAMED SRN
- US-MF-000003047
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 0ae1d273-874e-4db3-9acc-1f3a0b302a53 61 fields · synced Jun 17, 2026