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Spring handles, HF
EUDAMEDFDA UDIClass I (EU MDR)
Ref 8393.975Model 10000201321
Identity
- Trade Name
- NA FDA UDI
- Generic Name
- Endoscopic electrosurgical handpiece/electrode, bipolar, reusable FDA UDI
- Device Name
- Spring handles, HF EUDAMEDSPRING HANDLE BIPO non-rotatable, with bipolar HF-connection, for use with grasping forceps inserts 8393704, 8393705, 8393714, 8393724, 8393725, 8393727, reusable FDA UDI
- Model / Reference
- 10000201321 EUDAMED8393.975 EUDAMED8393975 FDA UDI
- Description
- SPRING HANDLE BIPO non-rotatable, with bipolar HF-connection, for use with grasping forceps inserts 8393704, 8393705, 8393714, 8393724, 8393725, 8393727, reusable FDA UDI
Identifiers
- Catalog Number
- 8393.975 FDA UDI
- Primary DI / UDI-DI
- 04055207016374 EUDAMEDFDA UDI
- Basic UDI-DI
- 405520727052019-0018406PA EUDAMED
- Direct Marketing DI
- 04055207016374 EUDAMED
- FDA Product Code
- GEI FDA UDI
- EMDN Code
- L180402 ENDOSCOPIC ELECTROSURGERY FORCEPS, REUSABLE EUDAMED
- GMDN Term
- Endoscopic electrosurgical handpiece/electrode, bipolar, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
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
No
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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Spring handles, HF by Richard Wolf GmbH — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 405520727052019-0018406PA | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Richard Wolf GmbH
- EUDAMED SRN
- DE-MF-000007048
Sources (2)
- EUDAMED 8cfc80fa-8971-4c8a-8f08-7706283f8479 61 fields · synced Jun 17, 2026
- FDA UDI bfb36a03-412a-4a9b-9b66-07cc4008a3b2 35 fields · synced May 30, 2026