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Patho Cutter-Ii 35ﾟ
EUDAMEDClass A (EU MDR)
Ref 08-635-1 Model PATHO CUTTER-II 35ﾟ
by Erma Inc.
Identity
- Trade Name
- PATHO CUTTER-II 35ﾟ EUDAMED
- Device Name
- Patho Cutter II EUDAMED
- Model / Reference
- PATHO CUTTER-II 35ﾟ EUDAMED08-635-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 14560196157238 EUDAMED
- Basic UDI-DI
- 456019615A0202V EUDAMED
- Direct Marketing DI
- 14560196157238 EUDAMED
- EMDN Code
- W0202059085 VARIOUS PROCESSING INSTRUMENTS FOR HYSTOLOGY / CYTOLOGY - CONSUMABLES EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
Yes
EUDAMED
Patho Cutter-Ii 35ﾟ by Erma Inc. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 456019615A0202V | Class A | Active |
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Manufacturer
- Manufacturer
- Erma Inc.
- EUDAMED SRN
- JP-MF-000028225
- Authorised Representative
- Umedwings Netherlands B.V. NL-AR-000000444
Sources (1)
- EUDAMED 7f24a4c6-d28f-43cc-b5e0-1768bb7e454d 61 fields · synced Jun 17, 2026