Identity
- Trade Name
- Bipolar Kabel; TUR/TCR; Storz EUDAMEDERBE FDA UDI
- Generic Name
- Electrical-only medical device connection cable, reusable FDA UDI
- Device Name
- Cable for electrosurgical unit EUDAMED
- Model / Reference
- 20196-118 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 20196-118 FDA UDI
- Primary DI / UDI-DI
- 04050147007031 EUDAMEDFDA UDI
- Basic UDI-DI
- 4050147Cable-HF-WX EUDAMED
- Direct Marketing DI
- 04050147007031 EUDAMED
- 510(k) Number
- K190823 FDA UDI
- FDA Product Code
- GEI FDA UDI
- EMDN Code
- K020180 SINGLE- AND BIPOLAR DEVICES, SINGLE USE - ACCESSORIES EUDAMED
- GMDN Term
- Electrical-only medical device connection cable, 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
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Electrical-only medical device connection cable, reusable
Erbe by Erbe Elektromedizin GmbH — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Electrical-only medical device connection cable, reusable.
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- Unimed — Unimed Medical Supplies, Inc. · Class II
- Symmetry Olsen — Olsen Medical · Class II
- Connection Cable — Shenzhen Keborui Electronics Co., Ltd · Class I
- TC-HEART LUNG DIN INTFC CA STOCKET — ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD. · Class II
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- ECG Cable — Edan Instruments,Inc. · Class I
Cleared under the same submission
K190823 also covers:
- ERBE — Erbe Elektromedizin GmbH
- ERBE — Erbe Elektromedizin GmbH
- ERBE — Erbe Elektromedizin GmbH
- ERBE — Erbe Elektromedizin GmbH
- ERBE — Erbe Elektromedizin GmbH
- ERBE — Erbe Elektromedizin GmbH
- ERBE — Erbe Elektromedizin GmbH
- ERBE — Erbe Elektromedizin GmbH
- ERBE — Erbe Elektromedizin GmbH
- ERBE — Erbe Elektromedizin GmbH
- ERBE — Erbe Elektromedizin GmbH
- ERBE — Erbe Elektromedizin GmbH
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Erbe Elektromedizin GmbH
Sources (2)
- FDA UDI 4a587836-25d9-4141-82cb-f7b0852b40d8 36 fields · synced Jul 25, 2026
- EUDAMED db7d23c1-efd9-4907-9235-8ad9bea9af2b 61 fields · synced Jul 25, 2026