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Modular handles, HF
EUDAMEDFDA UDIClass I (EU MDR)
Ref 83930074Model 10000201552
Identity
- Trade Name
- ERAGON MODULAR FDA UDI
- Generic Name
- Endoscopic electrosurgical handpiece/electrode, monopolar, reusable FDA UDI
- Device Name
- Modular handles, HF EUDAMEDHANDLE PISTOL SHAPED MONO with monopolar HF connection, for use with all insulated ERAGON outer sheath tubes, reusable FDA UDI
- Model / Reference
- 10000201552 EUDAMED83930074 EUDAMEDFDA UDI
- Description
- HANDLE PISTOL SHAPED MONO with monopolar HF connection, for use with all insulated ERAGON outer sheath tubes, reusable FDA UDI
Identifiers
- Catalog Number
- 83930074 FDA UDI
- Primary DI / UDI-DI
- 04055207026625 EUDAMEDFDA UDI
- Basic UDI-DI
- 405520718052021-0000058G5 EUDAMED
- FDA Product Code
- GCJ FDA UDI
- EMDN Code
- L180402 ENDOSCOPIC ELECTROSURGERY FORCEPS, REUSABLE EUDAMED
- GMDN Term
- Endoscopic electrosurgical handpiece/electrode, monopolar, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 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
Modular 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 | 405520718052021-0000058G5 | 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 675ce450-3386-4c1f-9ae2-4130fd5c3ce2 61 fields · synced Jun 18, 2026
- FDA UDI b45cc8bd-70dd-4168-8653-8b446a0994ae 35 fields · synced May 30, 2026