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CEDIA Propoxyphene Assay
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref 100171Ref 100170
Identity
- Trade Name
- CEDIA Propoxyphene Assay FDA UDI
- Generic Name
- Propoxyphene IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- CEDIA Propoxyphene Assay EUDAMED
- Model / Reference
- 100171 EUDAMEDFDA UDI100170 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00884883004283 EUDAMEDFDA UDI00884883004221 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00884883004283 EUDAMEDB-00884883004221 EUDAMED
- 510(k) Number
- K951133 FDA UDI
- FDA Product Code
- JXN FDA UDI
- EMDN Code
- W0102090115 PROPOXYPHENE EUDAMED
- GMDN Term
- Propoxyphene IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA UDI
- Regulation Number
- 862.3700 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
CEDIA Propoxyphene Assay by Microgenics Corporation — Class IVD General — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-00884883004283 | 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 (4)
- EUDAMED c25064f5-08ec-435b-ae9b-386ddab3064a 61 fields · synced Jul 25, 2026
- FDA UDI cd8f3c17-14b6-4b4a-8e65-5d75ef207cd5 33 fields · synced May 29, 2026
- FDA UDI 6132e14c-e867-415f-8869-df72ea530ec4 33 fields · synced May 30, 2026
- EUDAMED e6e3acd3-4231-454b-9640-32a785391215 61 fields · synced Jul 9, 2026