Identity
- Trade Name
- Surestep EUDAMED
- Device Name
- SureStep HEKO - Prefabricated EUDAMED
- Model / Reference
- 1845-XL-BLK-RT EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810080701410 EUDAMED
- Basic UDI-DI
- 008100807018458J EUDAMED
- Direct Marketing DI
- 00810080701410 EUDAMED
- EMDN Code
- Y061209 KNEE 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 | 008100807018458J | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Surestep, LLC
- EUDAMED SRN
- US-MF-000003047
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 6c2eb9e3-13e5-4031-9c5a-3732a444373a 61 fields · synced Jun 19, 2026