CEDIA PPX/METD Cutoff Calibrator
EUDAMEDFDA UDIClass IVD General (EU MDR)
Identity
- Trade Name
- CEDIA PPX/METD Cutoff Calibrator FDA UDI
- Generic Name
- Multiple drugs of abuse IVD, calibrator FDA UDI
- Device Name
- CEDIA PPX/METD Cutoff Calibrator EUDAMED
- Model / Reference
- 1662848 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00884883001978 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00884883001978 EUDAMED
- FDA Product Code
- DLJ FDA UDI
- EMDN Code
- W0102090110,W0102090115 EUDAMED
- GMDN Term
- Multiple drugs of abuse IVD, calibrator FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA UDI
- Regulation Number
- 862.3200 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Contains Latex
No
Human Tissues
Yes
Animal Tissues
Yes
Microbial Substances
No
Reagent
Yes
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
The CEDIA PPX/METD Cutoff Calibrator is a precision medical device designed for accurate and reliable microsurgical dissection during endoscopic procedures. Its high-precision calibration ensures precise measurements, allowing for more precise dissections and enhanced surgical outcomes.
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/IVDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-00884883001978 | Class IVD General | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD General | Pending data |
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Manufacturer
- Manufacturer
- Microgenics Corporation
- EUDAMED SRN
- US-MF-000030375
- Authorised Representative
- B·R·A·H·M·S GmbH DE-AR-000026031
Sources (2)
- EUDAMED 01dedd1f-8e47-4996-863e-fcf59c459eb4 61 fields · synced Jul 15, 2026
- FDA UDI fa281689-e616-48c0-95df-72e546a459c6 32 fields · synced May 30, 2026