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Collection & Transport System, Non-Sterile
EUDAMEDClass A (EU MDR)
Ref Ut-117-W
Identity
- Device Name
- Collection & Transport System, Non-Sterile EUDAMED
- Model / Reference
- Ut-117-W EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00609576900433 EUDAMED
- Basic UDI-DI
- 0609576TMNSCD3L EUDAMED
- EMDN Code
- A1102 SAMPLE COLLECTION SWABS WITH TRANSPORT MEDIUM EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
Collection & Transport System, Non-Sterile by Puritan Medical Products Company Llc — 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 | 0609576TMNSCD3L | Class A | Active |
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Manufacturer
- Manufacturer
- Puritan Medical Products Company
- EUDAMED SRN
- US-MF-000007051
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 9c18d930-c392-44f5-893a-170406cdd3f7 61 fields · synced Jun 11, 2026