Identity
- Trade Name
- Limulus Amebocyte Lysate (Gel Method) EUDAMED
- Device Name
- Limulus Amebocyte Lysate (Gel Method) EUDAMED
- Model / Reference
- RG025025 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 6978918720096 EUDAMED
- Basic UDI-DI
- 697891872LAL001RZ EUDAMED
- Direct Marketing DI
- 6978918720096 EUDAMED
- EMDN Code
- W0503900101 AGITATION RODS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Spain 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
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Limulus Amebocyte Lysate (Gel Method) by Xiamen Bioendo Technology Co., Ltd. — 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 | 697891872LAL001RZ | Class A | Active |
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Manufacturer
- Manufacturer
- Xiamen Bioendo Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000027676
- Authorised Representative
- JOYSUN GROUP S.L.U ES-AR-000043666
Sources (1)
- EUDAMED f0a7a5cd-e331-42f6-9adc-7ee6bef6f855 61 fields · synced Jul 9, 2026