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Soft Rehabilitation Glove
EUDAMEDClass I (EU MDR)
Ref SY-HRC15GRef SY-HRC15ERef SY-HRE12GRef SY-HRF12Ref SY-HRC11Ref SY-HRE12ERef SY-HRC10Ref SY-HRC12ERef SY-HRE12
Identity
- Trade Name
- Soft Rehabilitation Glove EUDAMED
- Device Name
- Soft Rehabilitation Glove EUDAMED
- Model / Reference
- SY-HRC15G EUDAMEDSY-HRC15E EUDAMEDSY-HRE12G EUDAMEDSY-HRF12 EUDAMEDSY-HRC11 EUDAMEDSY-HRE12E EUDAMEDSY-HRC10 EUDAMEDSY-HRC12E EUDAMEDSY-HRE12 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973408900538 EUDAMED06973408900521 EUDAMED06973408900514 EUDAMED06973408900736 EUDAMED06973408900040 EUDAMED06973408900507 EUDAMED06973408900385 EUDAMED06973408900460 EUDAMED06973408900729 EUDAMED
- Basic UDI-DI
- 697340890002KC EUDAMED
- Direct Marketing DI
- 06973408900538 EUDAMED06973408900521 EUDAMED06973408900514 EUDAMED06973408900736 EUDAMED06973408900040 EUDAMED06973408900507 EUDAMED06973408900385 EUDAMED06973408900460 EUDAMED06973408900729 EUDAMED
- EMDN Code
- V0899 MEDICAL SUPPORT EQUIPMENT - OTHER EUDAMEDZ120603 PASSIVE REHABILITATIVE GYMNASTICS EQUIPMENT 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
Soft Rehabilitation Glove by Shanghai SiYi Intelligent Technology 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 | 697340890002KC | Class I | Active |
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Manufacturer
- Manufacturer
- Shanghai SiYi Intelligent Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000038665
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (9)
- EUDAMED 04758d6d-70ae-44e5-94fd-cc2ae3afdb01 61 fields · synced Jul 25, 2026
- EUDAMED b9b0b579-cd7c-4351-8aa5-b7571ed43bd4 61 fields · synced May 17, 2026
- EUDAMED 462ea366-101f-4722-950e-ee0078e25fb0 61 fields · synced May 17, 2026
- EUDAMED 953109d4-aa36-46f0-b05e-f3b556c36b5d 61 fields · synced May 17, 2026
- EUDAMED 372bf6ff-0ac7-4715-b3bd-74ac6161fb49 61 fields · synced May 18, 2026
- EUDAMED 56803c1a-52fb-46d6-9097-45028399f595 61 fields · synced May 18, 2026
- EUDAMED 5d062221-d397-4f89-b2be-147f558f0021 61 fields · synced May 18, 2026
- EUDAMED 13392b2b-52e8-4b3a-ba6b-9a3013d212e8 61 fields · synced May 18, 2026
- EUDAMED 45383112-6c51-44ad-8591-6dbb544942c1 61 fields · synced May 19, 2026