Identity
- Trade Name
- STEPTY EUDAMED
- Device Name
- STEPTY EUDAMED
- Model / Reference
- No.80 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 14987167070097 EUDAMED
- Basic UDI-DI
- 4987167STP_H3 EUDAMED
- Unit of Use DI
- 84987167070096 EUDAMED
- EMDN Code
- M040599 HAEMOSTATIC DRESSINGS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
Yes
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
Stepty by Nichiban Co., Ltd. — 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 | 4987167STP_H3 | Class I | Active |
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Manufacturer
- Manufacturer
- Nichiban Co., Ltd.
- EUDAMED SRN
- JP-MF-000004197
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 4b3ec6b5-e5b1-45f8-aae6-51ebc97027b0 61 fields · synced Jul 20, 2026