Identity
- Trade Name
- Pumpeneinheit plus EUDAMEDERBE FDA UDI
- Generic Name
- Water jet knife system pump-cartridge FDA UDI
- Device Name
- Pump cartridge for ERBEJET 2, SU EUDAMEDPump cartridge plus for ERBEJET® 2 FDA UDI
- Model / Reference
- 20150-301 EUDAMEDFDA UDI
- Description
- Pump cartridge plus for ERBEJET® 2 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04050147020184 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04050147020184 EUDAMED
- 510(k) Number
- K231023 FDA UDI
- FDA Product Code
- FQH FDA UDI
- EMDN Code
- Z120106 HYDRODISSECTORS EUDAMED
- GMDN Term
- Water jet knife system pump-cartridge FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5475 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
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
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Water jet knife system pump-cartridge
Erbe by Erbe Elektromedizin GmbH — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Water jet knife system pump-cartridge.
- ERBE — Erbe Elektromedizin GmbH · Class II
Cleared under the same submission
K231023 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
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
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 d9b65557-144e-40ca-b3f3-3f9ac8415cce 35 fields · synced Jun 20, 2026
- EUDAMED 395caba3-b3a7-49d0-94d0-79d54e05e31e 61 fields · synced Jun 20, 2026