Identity
- Trade Name
- APCr EUDAMED
- Device Name
- APC Resistance EUDAMED
- Model / Reference
- 08013934190 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07613336155448 EUDAMED07640175460099 EUDAMED
- Basic UDI-DI
- B-07613336155448 EUDAMED76401754608013934190QZ EUDAMED
- EMDN Code
- W0103020610 APC RESISTANCE EUDAMED
Classification
- Device Class
- Class IVD General EUDAMEDClass B EUDAMED
- Market of Registration
- Greece EUDAMEDGermany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
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
APCr by Pentapharm AG — Class IVD General — IVDR, IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | B-07613336155448 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-07613336155448 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Pentapharm AG
- EUDAMED SRN
- CH-MF-000020620
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED c220cbde-ba70-4681-b8d5-306a84371358 61 fields · synced Jul 11, 2026
- EUDAMED 7e9cd784-73ab-4edd-8288-c4b62d44dad9 61 fields · synced May 19, 2026