Identity
- Trade Name
- Foot Switch EUDAMEDDophi FDA UDI
- Generic Name
- Foot-switch, electrical FDA UDI
- Device Name
- Foot Switch EUDAMEDFDA UDI
- Model / Reference
- SJ-A01 EUDAMEDFDA UDI
- Description
- Foot Switch FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06972304751411 EUDAMEDFDA UDI
- Basic UDI-DI
- 69723047500116S EUDAMED
- 510(k) Number
- K190052 FDA UDI
- FDA Product Code
- GEI FDA UDI
- EMDN Code
- K02030199 RADIOFREQUENCY SURGERY INSTRUMENTS, SINGLE-USE - OTHER 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
- Finland 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
Yes
FDA UDI
Serial Number
No
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
K190052 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.
- 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 8c5be09c-a8bc-4454-b514-fb3e9e45831b 34 fields · synced Jun 19, 2026
- EUDAMED c5d3147e-6b7e-417d-8ae6-f502f51c6826 61 fields · synced Jun 19, 2026