Identity
- Trade Name
- rebless EUDAMEDFDA UDI
- Generic Name
- Ankle continuous passive motion exerciser FDA UDI
- Device Name
- rebless EUDAMED
- Model / Reference
- RHSW EUDAMEDFDA UDI2018 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800101600015 EUDAMEDFDA UDI
- Basic UDI-DI
- 880010160RHSWAN EUDAMED
- Direct Marketing DI
- 08800101600015 EUDAMED
- FDA Product Code
- BXB FDA UDI
- EMDN Code
- Z12069099 VARIOUS PHYSIOTHERAPY AND REHABILITATION INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Ankle continuous passive motion exerciser FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.5380 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
rebless by H Robotics Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 880010160RHSWAN | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- H Robotics Inc.
- EUDAMED SRN
- KR-MF-000011627
- Authorised Representative
- KTR Europe GmbH DE-AR-000005685
Sources (2)
- EUDAMED 4cc11a15-b869-4884-807d-da7360c03ef7 61 fields · synced May 30, 2026
- FDA UDI 6f273cea-bee1-4a50-9bf9-c6086e0edad6 34 fields · synced May 30, 2026