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Buffer Tablets pH 6.4 to make 1L (1000ml)
EUDAMEDClass A (EU MDR)
Ref AE31-002Model Buffer Tablets
Identity
- Trade Name
- Buffer Tablets pH 6.4 to make 1L (1000ml) EUDAMED
- Model / Reference
- Buffer Tablets EUDAMEDAE31-002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060405296809 EUDAMED
- Basic UDI-DI
- 505591470AERG EUDAMED
- EMDN Code
- W010399 HAEMATOLOGY / HAEMOSTASIS / IMMUNOHAEMATOLOGY / HISTOLOGY / CYTOLOGY REAGENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Northern Ireland 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
This medical device is a sterile buffer solution made with pH 6.4, suitable for use in various applications requiring a stable and neutral environment.
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 | 505591470AERG | Class A | Active |
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Manufacturer
- Manufacturer
- Atom Scientific Ltd
- EUDAMED SRN
- UK-MF-000046578
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED c22ff03e-e239-4e0d-9009-e77dfeceb1b3 61 fields · synced Aug 3, 2026