Identity
- Trade Name
- Nuclease-Free Water EUDAMED
- Device Name
- Nuclease-Free Water EUDAMED
- Model / Reference
- 757003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10888234400448 EUDAMED
- Basic UDI-DI
- 88823411W01030403C004LKM EUDAMED
- Direct Marketing DI
- 10888234400448 EUDAMED
- EMDN Code
- W01030403 HLA ANTIGEN TYPING EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
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
Category: HLA class I & II antigen tissue typing IVD, kit, multiplex
Nuclease-Free Water by Immucor GTI Diagnostics, Inc. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 88823411W01030403C004LKM | Class A | Active |
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Manufacturer
- Manufacturer
- Immucor GTI Diagnostics, Inc
- EUDAMED SRN
- US-MF-000020921
- Authorised Representative
- IMMUCOR Medizinische Diagnostik GmbH DE-AR-000007083
Sources (1)
- EUDAMED 2c67c67d-b4ef-469f-a8d9-bbd562a318e6 61 fields · synced Jun 19, 2026