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Connection cables for electrosurgery
EUDAMEDFDA UDIClass I (EU MDR)
Ref 8108.231Model 10000201069
Identity
- Trade Name
- SHARK/S-LINE FDA UDI
- Generic Name
- Electrical-only medical device connection cable, reusable FDA UDI
- Device Name
- Connection cables for electrosurgery EUDAMEDHF BIPOLAR CONNECTING CABLE L 3M for KLS-Martin generators, M-Version, reusable FDA UDI
- Model / Reference
- 10000201069 EUDAMED8108.231 EUDAMED8108231 FDA UDI
- Description
- HF BIPOLAR CONNECTING CABLE L 3M for KLS-Martin generators, M-Version, reusable FDA UDI
Identifiers
- Catalog Number
- 8108.231 FDA UDI
- Primary DI / UDI-DI
- 04055207000892 EUDAMEDFDA UDI
- Basic UDI-DI
- 405520720052019-0017627DC EUDAMED
- Direct Marketing DI
- 04055207000892 EUDAMED
- FDA Product Code
- FAS FDA UDI
- EMDN Code
- Z12010980 ELECTROSURGERY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Electrical-only medical device connection cable, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 876.4300 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- Not 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
Dimensions & Sizes
- Size
- Length — 3 Meter FDA UDI
Connection cables for electrosurgery 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 | 405520720052019-0017627DC | 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 63973972-cd05-4f7d-9e63-9654c7e96f19 61 fields · synced Jul 15, 2026
- FDA UDI f0d7a892-9e70-496e-801f-c122ca347ba8 37 fields · synced May 30, 2026