Identity
- Trade Name
- Microwave Ablation Generator EUDAMEDDophi FDA UDI
- Generic Name
- Microwave ablation system generator FDA UDI
- Device Name
- Microwave Ablation System EUDAMEDMicrowave Ablaton Generator FDA UDI
- Model / Reference
- M150E EUDAMEDFDA UDI
- Description
- Microwave Ablaton Generator FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06972304750292 EUDAMEDFDA UDI
- Basic UDI-DI
- 69723047500026R EUDAMED
- 510(k) Number
- K183153 FDA UDI
- FDA Product Code
- NEY FDA UDI
- EMDN Code
- Z120608 MICROWAVE THERAPY EQUIPMENT EUDAMED
- GMDN Term
- Microwave ablation system generator FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Market of Registration
- Cyprus EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
Yes
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Microwave ablation system generator
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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Also classified as Microwave ablation system generator.
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- HYGEA — Hygea Medical Technology Co., Ltd. · Class II
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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
MDR
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 a9480eb2-7e7f-4739-86c9-e4a50d6a26aa 34 fields · synced Jul 8, 2026
- EUDAMED cfc792bc-e2bf-40c1-ac56-23179707a972 61 fields · synced Jun 18, 2026