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Instrument Table
EUDAMEDFDA UDIClass I (EU MDR)
Ref K2XXCL-24-00001Model CIT-4100, CIT-4200
Identity
- Trade Name
- Instrument Table CIT-4100 FDA UDI
- Generic Name
- Instrument table FDA UDI
- Device Name
- Instrument Table EUDAMEDInstrument Table CIT-4100 FDA UDI
- Model / Reference
- CIT-4100, CIT-4200 EUDAMEDK2XXCL-24-00001 EUDAMEDCIT-4100 FDA UDI
- Description
- Instrument Table CIT-4100 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800019600978 EUDAMEDFDA UDI
- Basic UDI-DI
- 88000196IT001ED EUDAMED
- Direct Marketing DI
- 08800019600978 EUDAMED
- FDA Product Code
- HRJ FDA UDI
- EMDN Code
- V0899 MEDICAL SUPPORT EQUIPMENT - OTHER EUDAMED
- GMDN Term
- Instrument table FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 886.4855 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
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
No
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Instrument Table by Huvitz Co., Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 88000196IT001ED | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Huvitz Co., Ltd.
- EUDAMED SRN
- KR-MF-000015802
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED e0aac548-cb33-444e-a993-6e050cb234fd 61 fields · synced Jun 18, 2026
- FDA UDI ea825c2d-1602-46bd-9890-fd077863e8db 33 fields · synced May 30, 2026