Identity
- Trade Name
- ERBE APC 2 (für VIO®) EUDAMEDERBE FDA UDI
- Generic Name
- Argon-enhanced electrosurgical system gas delivery unit FDA UDI
- Device Name
- APC 2 Module EUDAMEDAPC 2 (for VIO®) Argon Plasma Coagulation Unit FDA UDI
- Model / Reference
- 10134-000 EUDAMEDFDA UDI
- Description
- APC 2 (for VIO®) Argon Plasma Coagulation Unit FDA UDI
Identifiers
- Catalog Number
- 10134-000 FDA UDI
- Primary DI / UDI-DI
- 04050147000193 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04050147000193 EUDAMED
- 510(k) Number
- K024047 FDA UDI
- FDA Product Code
- GEI FDA UDI
- EMDN Code
- Z12010903 ARGON ELECTROSURGICAL UNITS (ESU) EUDAMED
- GMDN Term
- Argon-enhanced electrosurgical system gas delivery unit FDA UDI
Classification
- Device Class
- Class IIb 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
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Argon-enhanced electrosurgical system gas delivery unit
Erbe by Erbe Elektromedizin GmbH — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
K024047 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Erbe Elektromedizin GmbH
Sources (2)
- FDA UDI f8a67b91-0cae-4d38-bee0-acdc817948d8 37 fields · synced Aug 3, 2026
- EUDAMED 56a25266-348c-4523-a910-453bcf889d25 61 fields · synced Aug 3, 2026