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MagCTL Collection Tube (5 tubes)
EUDAMEDClass A (EU MDR)
Ref MXCT-5Model Device for isolation of nucleic acids from sample collection/lysis buffer
Identity
- Trade Name
- MagCTL Collection Tube (5 tubes) EUDAMED
- Device Name
- MagCTL Collection Tube (5 tubes) EUDAMED
- Model / Reference
- Device for isolation of nucleic acids from sample collection/lysis buffer EUDAMEDMXCT-5 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850049735490 EUDAMED
- Basic UDI-DI
- 0850049735MXCT-57N EUDAMED
- Direct Marketing DI
- 00850049735490 EUDAMED
- EMDN Code
- W05019099 SAMPLES COLLECTION DEVICES - OTHER 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
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
MagCTL Collection Tube (5 tubes) by MagBio Genomics, Inc. — 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 | 0850049735MXCT-57N | Class A | Active |
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Manufacturer
- Manufacturer
- MagBio Genomics, Inc.
- EUDAMED SRN
- US-MF-000038221
- Authorised Representative
- CEpartner4U NL-AR-000000111
Sources (1)
- EUDAMED 74153deb-00d4-42a5-b3ef-8f3339e6e10d 61 fields · synced Jul 8, 2026