joimax® Versicon® Spine Pump
EUDAMEDFDA UDIClass IIa (EU MDR)
by Joimax GmbH
Identity
- Trade Name
- joimax® Versicon® Spine Pump EUDAMEDVersicon® FDA UDI
- Generic Name
- Surgical irrigation pump FDA UDI
- Device Name
- joimax® Versicon® Spine Pump EUDAMEDFDA UDI
- Model / Reference
- JISP3000 EUDAMEDFDA UDI
- Description
- joimax® Versicon® Spine Pump FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04250337105343 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04250337105343 EUDAMED42503371VERSPUMSL EUDAMED
- Direct Marketing DI
- 04250337105343 EUDAMED
- FDA Product Code
- FQH FDA UDI
- EMDN Code
- Z12019007 IRRIGATORS EUDAMED
- GMDN Term
- Surgical irrigation pump 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
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
Yes
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
No
Category: Endoscopic spray catheter, single-use
joimax® Versicon® Spine Pump by Joimax GmbH — Class IIa — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endoscopic spray catheter, single-use.
- Spray Catheter — Micro-Tech (Nanjing) Co., Ltd. · Class I
- Measuring Jug 250 — Chaplet International Pvt Ltd · Class I
- IRRIGATION SET SIMPLE WAY — LD Medicare · Class IIa
- Spray Catheter — Micro-Tech (Nanjing) Co., Ltd. · Class I
- RoboClean — Era Endoscopy Srl · Class IIa
- Forceps Jar 30 x 80 — Chaplet International Pvt Ltd · Class I
- Trans Urethral Resection Set (TUR Set) — Poly Medicure Limited · Class IIa
- Measuring Jug 500 — Chaplet International Pvt Ltd · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
CE/MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-04250337105343 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-04250337105343 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Joimax GmbH
- EUDAMED SRN
- DE-MF-000009201
Sources (3)
- EUDAMED 39091052-12b8-4e03-b04d-a67e89f0ff02 61 fields · synced Jul 8, 2026
- FDA UDI 7acf143e-627a-4dc8-9913-1437af4acb38 34 fields · synced May 30, 2026
- EUDAMED 98f9cfe4-83da-4727-b618-835b858b6783 61 fields · synced Jun 18, 2026