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joimax® Arthroscope Combo
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref AS4030175
by Joimax GmbH
Identity
- Trade Name
- joimax® Arthroscope Combo EUDAMEDjoimax® FDA UDI
- Generic Name
- Rigid optical arthroscope, reusable FDA UDI
- Device Name
- joimax® Arthroscope Combo EUDAMEDjoimax® Arthroscope Combo WL 175 mm / OD 4.0 mm / 30° FDA UDI
- Model / Reference
- AS4030175 EUDAMEDFDA UDI
- Description
- joimax® Arthroscope Combo WL 175 mm / OD 4.0 mm / 30° FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04250337100027 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04250337100027 EUDAMED42503371ENSCARTFV EUDAMED
- Direct Marketing DI
- 04250337100027 EUDAMED
- 510(k) Number
- K051827 FDA UDI
- FDA Product Code
- HRX FDA UDI
- EMDN Code
- Z12021101 ARTHROSCOPES EUDAMED
- GMDN Term
- Rigid optical arthroscope, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 888.1100 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMEDEUDAMED
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
joimax® Arthroscope Combo by Joimax GmbH — Class IIa — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-04250337100027 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-04250337100027 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Joimax GmbH
- EUDAMED SRN
- DE-MF-000009201
Sources (3)
- EUDAMED 8b1c793a-2c81-4cbf-94f0-d7509d4bcb23 61 fields · synced Jun 19, 2026
- FDA UDI f7eaf069-e997-47f0-974f-55f543e4a97c 35 fields · synced May 30, 2026
- EUDAMED 681e2e40-211c-4b4b-973a-29bfa7a99134 61 fields · synced Jun 19, 2026