Identity
- Trade Name
- IgM; Polyclonal (Ready-To-Use) 25 mL EUDAMED
- Device Name
- Primary Antisera for Immunohistology EUDAMED
- Model / Reference
- A00063-0025 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810108710806 EUDAMED
- Basic UDI-DI
- 081010871W01030709FJ EUDAMED
- Direct Marketing DI
- 00810108710806 EUDAMED
- EMDN Code
- W01030709 PRIMARY ANTISERA FOR IMMUNOHISTOLOGY EUDAMED
- Models / Variants
- IgM EUDAMEDPolyclonal (Ready-To-Use) 25 mL EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
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
IgM +1 more model by ScyTek Laboratories Inc. — Class C — IVDR — listed in EUDAMED — 2 models — 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 | 081010871W01030709FJ | Class C | Active |
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Manufacturer
- Manufacturer
- ScyTek Laboratories Inc.
- EUDAMED SRN
- US-MF-000023816
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 9893cf48-2488-4606-a4ef-6f6c2e141dfb 61 fields · synced Jun 18, 2026