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Copan Universal Transport Medium (UTM-RT) System
FDA 510(k)EUDAMEDClass I (US FDA 510(k))
510(k) K232357Ref 3U092N01Ref 331CRef 357CRef 356CRef 350C.DHIRef 349CRef 3E056NRef 3E101N01Ref 302CRef 360CRef 338CRef 359CRef 323CRef 307CRef 3E093N01.MLSRef 3U044NRef 347CRef 365CRef 361CRef 3U006NRef 348CRef 359CE.ARef 330C.DHI
Identity
- Trade Name
- UTM EUDAMEDUTM-RT EUDAMED
- Device Name
- UTM with nucleic acids preservation claim EUDAMEDUTM EUDAMED
- Model / Reference
- 3U092N01 EUDAMED331C EUDAMED357C EUDAMED356C EUDAMED350C.DHI EUDAMED349C EUDAMED3E056N EUDAMED3E101N01 EUDAMED302C EUDAMED360C EUDAMED338C EUDAMED359C EUDAMED323C EUDAMED307C EUDAMED3E093N01.MLS EUDAMED3U044N EUDAMED347C EUDAMED365C EUDAMED361C EUDAMED3U006N EUDAMED348C EUDAMED359CE.A EUDAMED330C.DHI EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18053326011556 EUDAMED08053326002984 EUDAMED18053326003131 EUDAMED18053326003124 EUDAMED08053326003073 EUDAMED08053326003066 EUDAMED08053326009716 EUDAMED18053326011808 EUDAMED18053326002837 EUDAMED18053326000505 EUDAMED18053326003018 EUDAMED18053326003155 EUDAMED18053326002936 EUDAMED18053326002912 EUDAMED18053326011310 EUDAMED08053326009440 EUDAMED18053326003056 EUDAMED18053326003216 EUDAMED18053326003162 EUDAMED18053326003261 EUDAMED08053326000478 EUDAMED18053326001052 EUDAMED08053326002960 EUDAMED
- Basic UDI-DI
- 80533260BD0560AM004B6 EUDAMED80533260CD0440AM004AG EUDAMED80533260BD0260AM0049D EUDAMED
- 510(k) Number
- K232357 FDA 510(k)
- FDA Product Code
- JSM FDA 510(k)
- EMDN Code
- W050301020101 SAMPLES ANALYSES, PLASTIC TUBES WITH ADDITIVES EUDAMED
Classification
- Device Class
- Class A EUDAMEDClass I FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.2390 FDA 510(k)
- Regulation Number
- 866.2390 FDA 510(k)
- Market of Registration
- Italy EUDAMED
- Advisory Committee
- Microbiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
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
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Copan Universal Transport Medium (UTM-RT) System by Copan Italia Spa — Class I — IVDR, FDA_510K — listed in FDA 510(k), EUDAMED — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
IVDR
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class I | Active |
| FDA 510(k) | United States | FDA_510K | K232357 | Class I | Active |
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Manufacturer
- Manufacturer
- Copan Italia Spa
Sources (24)
- FDA 510(k) K232357 24 fields · synced Sep 17, 2026
- EUDAMED 9823d910-c8bc-41e5-9b85-56f813b08bc9 61 fields · synced Jul 8, 2026
- EUDAMED d209491a-094d-4010-a677-d6cf0e55c719 61 fields · synced Jul 9, 2026
- EUDAMED a777da88-5686-4ffa-8d65-b58260189370 61 fields · synced Jul 9, 2026
- EUDAMED e85bdd79-d0dd-48fe-8f51-baefadceb123 61 fields · synced Jul 9, 2026
- EUDAMED c1ad46cf-5c22-4b64-91d7-928ef39a79b5 61 fields · synced Jul 9, 2026
- EUDAMED 9105b242-43a1-492a-83b3-ecbd7e9ec255 61 fields · synced Jul 11, 2026
- EUDAMED 360652fc-43d3-4fe3-828f-e7d9fa4df656 61 fields · synced Jul 11, 2026
- EUDAMED 6fe5f9e8-a277-4eb9-9a2b-23c07af54258 61 fields · synced Jul 12, 2026
- EUDAMED cf61770b-38c2-4f2f-bec2-55379afde7f6 61 fields · synced Jul 13, 2026
- EUDAMED 10acfd50-31bf-413c-a9bd-434e7d37500b 61 fields · synced Jul 16, 2026
- EUDAMED a7418f2b-0430-4db7-8280-03564104728e 61 fields · synced Jul 21, 2026
- EUDAMED 40450fb5-9e54-4686-b823-16d64f71d6b4 61 fields · synced Jul 21, 2026
- EUDAMED b2013552-5d6f-4fba-b494-01ef8ee3b03f 61 fields · synced Jul 23, 2026
- EUDAMED a6a79ff9-402d-4d5a-b2fb-86c9fe988e9a 61 fields · synced Jul 23, 2026
- EUDAMED 6ae627a5-5cfa-4cc4-a8d4-a09b596b3880 61 fields · synced Jul 24, 2026
- EUDAMED 5acd88cf-d7e1-454e-813a-73ca32cc4bca 61 fields · synced Jul 26, 2026
- EUDAMED 50b72ee6-b58e-4a17-884b-b1f47dea3a88 61 fields · synced Jul 26, 2026
- EUDAMED c5d60717-fafb-4f87-a657-2c2e4b08f8ea 61 fields · synced Jul 30, 2026
- EUDAMED d276ca8e-f496-4760-b7be-94381c293259 61 fields · synced Aug 1, 2026
- EUDAMED 5aabfac9-8396-4345-b628-78318fd2d7b7 61 fields · synced Aug 4, 2026
- EUDAMED 1da606a8-40ca-47cf-9813-4af09ed125ca 61 fields · synced Aug 4, 2026
- EUDAMED 85707fc5-a90c-427e-9847-5ec4d4ba619e 61 fields · synced Sep 17, 2026
- EUDAMED 12954f98-0c9a-4ce0-8162-323c7e485644 61 fields · synced Sep 17, 2026