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Modular handles, non HF
EUDAMEDFDA UDIClass I (EU MDR)
Ref 83930085Model 10000201035
Identity
- Trade Name
- ERAGON AXIAL FDA UDI
- Generic Name
- Endoscopic electrosurgical handpiece/electrode, monopolar, reusable FDA UDI
- Device Name
- Modular handles, non HF EUDAMEDHANDLE AXIAL with locking mechanism, non-rotatable, without HF-connection, for use with all ERAGON outer sheath tubes, reusable FDA UDI
- Model / Reference
- 10000201035 EUDAMED83930085 EUDAMEDFDA UDI
- Description
- HANDLE AXIAL with locking mechanism, non-rotatable, without HF-connection, for use with all ERAGON outer sheath tubes, reusable FDA UDI
Identifiers
- Catalog Number
- 83930085 FDA UDI
- Primary DI / UDI-DI
- 04055207026663 EUDAMEDFDA UDI
- Basic UDI-DI
- 405520717012020-0017580B9 EUDAMED
- FDA Product Code
- GCJ FDA UDI
- EMDN Code
- L1204 LAPAROSCOPIC AND THORACOSCOPIC SURGERY 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, non 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 | 405520717012020-0017580B9 | 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 c6415859-5bb9-49fe-b103-60010b31bf03 61 fields · synced Jul 14, 2026
- FDA UDI 9688dcad-5db1-4bbb-95a6-f36980d565ec 35 fields · synced May 30, 2026