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Sample treatment reagents for use with MALDI-TOF MS
EUDAMEDClass A (EU MDR)
Ref 2701200023Model Type IIRef 2701200024Model Type III
Identity
- Trade Name
- Sample treatment reagents for use with MALDI-TOF MS EUDAMED
- Device Name
- Sample treatment reagents for use with MALDI-TOF MS EUDAMED
- Model / Reference
- Type II EUDAMED2701200023 EUDAMEDType III EUDAMED2701200024 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971025210641 EUDAMED06971025210658 EUDAMED
- Basic UDI-DI
- 69710252106411222004EW EUDAMED69710252106581222005KU EUDAMED
- Direct Marketing DI
- 06971025210641 EUDAMED06971025210658 EUDAMED
- EMDN Code
- W010499 MICROBIOLOGY TESTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Romania 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
Sample treatment reagents for use with MALDI-TOF MS by Zhuhai DL Biotech 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 | 69710252106411222004EW | Class A | Active |
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Manufacturer
- Manufacturer
- Zhuhai DL Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000036485
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED f4c40291-91fe-4b0b-82b1-e7ea6c3739c5 61 fields · synced Sep 18, 2026
- EUDAMED 0c9d9025-75e1-48b8-9965-ac0427e5a247 61 fields · synced May 18, 2026