Identity
- Trade Name
- Foot Switch EUDAMEDDophi FDA UDI
- Generic Name
- Foot-switch, electrical FDA UDI
- Device Name
- Foot Switch EUDAMEDFDA UDI
- Model / Reference
- SJ-B02 EUDAMEDFDA UDI
- Description
- Foot Switch FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06972304751435 EUDAMEDFDA UDI
- Basic UDI-DI
- 69723047500116S EUDAMED
- 510(k) Number
- K183153 FDA UDI
- FDA Product Code
- NEY FDA UDI
- EMDN Code
- Z120608 MICROWAVE THERAPY EQUIPMENT EUDAMED
- GMDN Term
- Foot-switch, electrical FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Market of Registration
- Greece EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
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
Yes
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Foot-switch, electrical
Dophi by Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
K183153 also covers:
- Dophi — Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.
- Dophi — Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.
- Dophi — Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.
- Dophi — Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.
- Dophi — Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.
- Dophi — Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.
- Dophi — Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.
- Dophi — Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
Sources (2)
- FDA UDI d960710f-cf7e-4bfb-8b0e-c36ce0e70447 34 fields · synced Jun 11, 2026
- EUDAMED 852048ba-735e-460f-9ffc-c489d1668c8e 61 fields · synced Jun 11, 2026