Identity
- Device Name
- TDL-5G EUDAMEDTDL-5G plus EUDAMED
- Model / Reference
- TDL-5G EUDAMEDTDL-5G plus EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976374330439 EUDAMED06976374330644 EUDAMED
- Basic UDI-DI
- 697637433TDL-5GQ7 EUDAMED697637433TDL-5GplusU2 EUDAMED
- EMDN Code
- W02069003 CENTRIFUGES 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
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Category: General-purpose centrifuge IVD
Tdl-5g by Zenith Lab (Jiangsu) Co., Ltd — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as General-purpose centrifuge IVD.
- DASH Apex 4 Centrifuge, Fisher — DRUCKER DIAGNOSTICS · Class I
- Allegra X-30, IVD, 100V, 50/60Hz — Beckman Coulter, Inc. · Class A
- Centrifuge 5920R — Eppendorf SE · Class A
- Thermo Scientific SL1 Plus-MD — Thermo Electron LED GmbH Zweigniederlassung Osterode · Class A
- Medical Centrifuge LX-210L750R — Qingdao Haier Biomedical Technology Co., Ltd. · Class A
- cence — HUNAN XIANG YI LABORATORY INSTRUMENT DEVELOPMENT CO.,LTD. · Class A
- 406 — GYROZEN · Class A
- cence — HUNAN XIANG YI LABORATORY INSTRUMENT DEVELOPMENT CO.,LTD. · Class A
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 | 697637433TDL-5GQ7 | Class A | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Zenith Lab (Jiangsu) Co., Ltd
- EUDAMED SRN
- CN-MF-000026595
- Authorised Representative
- Umedwings Netherlands B.V. NL-AR-000000444
Sources (2)
- EUDAMED c519e68c-b20b-4b7f-9006-a00a5c112ad7 61 fields · synced Jul 8, 2026
- EUDAMED f79683d5-d634-4a8c-abc9-531f914a2bc1 61 fields · synced May 19, 2026