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Sign in to claim this brandZhejiang Shuyou Surgical Instrument Co., Ltd
China·CN-MF-000025970
Last updated September 17, 2026
What Zhejiang Shuyou Surgical Instrument Co., Ltd makes
The company manufactures single-use electrosurgical devices, including monopolar and bipolar electrodes for open-surgery and endoscopic procedures, as well as disposable electrosurgical pads and multifunctional dissectors (electrosurgical pencils).
These devices are classified as Class I and Class IIb under EU regulations and are listed in the EUDAMED registry. The company is based in China.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Zhejiang Shuyou Surgical Instrument Co., Ltd primarily manufacture?
Zhejiang Shuyou Surgical Instrument Co., Ltd specializes in single-use electrosurgical devices. Their portfolio includes monopolar and bipolar electrodes for open-surgery and endoscopic procedures, as well as disposable electrosurgical pads and multifunctional dissectors (often referred to as electrosurgical pencils). These tools are designed for precise tissue cutting and coagulation during surgical interventions.
Where is Zhejiang Shuyou Surgical Instrument Co., Ltd based?
The company is headquartered in China, specifically in Zhejiang province. This geographic location influences its regulatory compliance framework, particularly for markets like the European Union, where device classification and registration requirements apply.
Are Zhejiang Shuyou Surgical Instrument Co., Ltd’s devices listed in any regulatory registries?
Yes, the company’s devices are listed in the EUDAMED registry, which is the European database for medical devices. This registry is used to track devices that have undergone conformity assessment procedures under EU regulations, such as CE marking. Listing in EUDAMED confirms the device’s presence in the EU market but does not imply approval—only that it has been registered for compliance purposes.
How are Zhejiang Shuyou Surgical Instrument Co., Ltd’s devices classified under EU regulations?
Under EU medical device regulations, Zhejiang Shuyou’s devices fall into Class I and Class IIb categories. Classification depends on factors like risk level, intended use, and interaction with the body. For example, disposable electrosurgical pads are typically Class I, while more complex devices like multifunctional dissectors (electrosurgical pencils) may be classified as Class IIb due to their higher risk potential during surgical procedures.
Why do some of Zhejiang Shuyou Surgical Instrument Co., Ltd’s devices fall into Class IIb rather than a lower risk class?
The classification of a device as Class IIb (rather than Class I or IIa) is determined by its intended use and associated risks. For instance, multifunctional dissectors (electrosurgical pencils) combine cutting, coagulation, and dissection functions, which increases their risk profile compared to simpler monopolar or bipolar electrodes. EU regulations categorize these devices as Class IIb because they require additional scrutiny to ensure safety and performance, such as clinical evaluation or involvement of a Notified Body during conformity assessment.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- China
- Address
- 3689#, East Yangguang Avenue, Huzhou City, Zhejiang, China
- Website
- shuyou-china.com
- —
- —
- [email protected]
- Phone
- —
- PRRC Contact
- Jialong Wu
- EUDAMED SRN
- CN-MF-000025970
- FDA FEI Number
- 3007728276
- DUNS Number
- —
Catalogue (332)
Page 3 of 7| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Disposable Electrode Serie | OB-1008S | FDA UDI | Class II | Active |
| Disposable Electrode Serie | P0016M | FDA UDI | Class II | Active |
| Disposable Electrode Series | P0021X | FDA UDI | Class II | Active |
| Disposable Electrode Serie | P0480 | FDA UDI | Class II | Active |
| Disposable Electrode Serie | OB-1010S | FDA UDI | Class II | Active |
| Disposable Electrode Serie | ⅥW-B012注吹球 | FDA UDI | Class II | Active |
| Disposable Electrode Serie | P1653 | FDA UDI | Class II | Active |
| Disposable Electrode Series | P0012 | FDA UDI | Class II | Active |
| Disposable Electrode Serie | OB-1515 | FDA UDI | Class II | Active |
| Peng's Multifunctional Operative Dissector(Electrosurgical Pencil) | 2A-D608-SG0013 | FDA UDI | Class II | Active |
| Disposable Electrode Serie | P0016 | FDA UDI | Class II | Active |
| Disposable Electrode Series | LE-25-202 | FDA UDI | Class II | Active |
| Disposable Electrode Serie | VIS-F005-SG032 | FDA UDI | Class II | Active |
| Disposable Electrode Series | P0012A | FDA UDI | Class II | Active |
| Peng's Multifunctional Operative Dissector(Electrosurgical Pencil) | IIIA-D000-SG001 | FDA UDI | Class II | Active |
| Disposable Electrode Serie | OB-5B | FDA UDI | Class II | Active |
| Disposable Electrode Serie | SG024 | FDA UDI | Class II | Active |
| Disposable Electrode Series | SY-IB-1 | FDA UDI | Class II | Active |
| Disposable Electrode Serie | P0017 | FDA UDI | Class II | Active |
| Disposable Electrode Serie | OB-3B | FDA UDI | Class II | Active |
| Disposable Electrode Serie | P0014A | FDA UDI | Class II | Active |
| Disposable Electrode Serie | ⅥS-F005吹管不粘 | FDA UDI | Class II | Active |
| Disposable Electrode Series | SG032NS | FDA UDI | Class II | Active |
| Disposable Electrode Serie | P0009 | FDA UDI | Class II | Active |
| Disposable Electrode Serie | P0019S | FDA UDI | Class II | Active |
| Disposable Electrode Serie | P0020S | FDA UDI | Class II | Active |
| Disposable Electrode Series | VIS-F005-SG021-NS | FDA UDI | Class II | Active |
| Disposable Electrode Serie | OB-0505S | FDA UDI | Class II | Active |
| Disposable Electrode Serie | P0013M | FDA UDI | Class II | Active |
| Disposable Electrode Serie | OB-2015 | FDA UDI | Class II | Active |
| Disposable Electrode Series | M1-SG001 | FDA UDI | Class II | Active |
| Disposable Electrode Serie | P0013 | FDA UDI | Class II | Active |
| Disposable Electrode Serie | P0015 | FDA UDI | Class II | Active |
| Disposable Electrode Serie | P0020 | FDA UDI | Class II | Active |
| Disposable Electrode Series | D3-SS02-FG001301 | FDA UDI | Class II | Active |
| Disposable Electrode Serie | P1651 | FDA UDI | Class II | Active |
| Disposable Electrode Serie | OB-5B | FDA UDI | Class II | Active |
| Disposable Electrode Serie | P0016AM | FDA UDI | Class II | Active |
| Disposable Electrode Serie | P0470 | FDA UDI | Class II | Active |
| Disposable Electrode Series | SG002NS | FDA UDI | Class II | Active |
| Disposable Electrodes | 03D04 | EUDAMED | Class IIb | Active |
| Disposable Electrodes | 03W13 | EUDAMED | Class IIb | Active |
| Disposable Electrodes | 03S02 | EUDAMED | Class IIb | Active |
| Disposable Electrodes | 03W04 | EUDAMED | Class IIb | Active |
| Disposable Electrodes | 03W12 | EUDAMED | Class IIb | Active |
| Disposable Electrodes | 03S10 | EUDAMED | Class IIb | Active |
| Disposable Electrodes | 03W16 | EUDAMED | Class IIb | Active |
| Disposable Electrodes | 03S12 | EUDAMED | Class IIb | Active |
| Disposable Electrodes | 03M01 | EUDAMED | Class IIb | Active |
| Disposable Electrodes | 03W01 | EUDAMED | Class IIb | Active |
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