Identity
- Trade Name
- AM3010TJ EUDAMED
- Device Name
- Astramax EUDAMED
- Model / Reference
- AM3010TJ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060413441345 EUDAMED
- Basic UDI-DI
- 506041344AM30XF EUDAMED
- Direct Marketing DI
- 05060413441345 EUDAMED
- EMDN Code
- Z12010701 FIXED SCIALYTIC LAMPS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Operating room light system
Am3010tj by Brandon Medical Company Limited — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Operating room light system.
- PWDII70DF CL K3 SATX13 — MAQUET SAS · Class I
- PWDII70SF SAT AIM CL K4 12 — MAQUET SAS · Class I
- PWDII50SF AIM MHS021 K4 1116 — MAQUET SAS · Class I
- PWDII55DF CL K4 SAX0810 — MAQUET SAS · Class I
- SLS 9000 — Avante · Class II
- PWDII75SF AIM MHS021 K3 081011 — MAQUET SAS · Class I
- HarmonyAIR — STERIS CORPORATION · Class II
- HarmonyAIR — STERIS CORPORATION · Class II
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 506041344AM30XF | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Brandon Medical Company Limited
- EUDAMED SRN
- GB-MF-000005501
- Authorised Representative
- RegTrac Limited IE-AR-000042448
Sources (1)
- EUDAMED eb619f50-b95b-40ad-9123-c6fedc1908f0 61 fields · synced Jul 9, 2026