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Caplugs/Evergreen
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 127-0017-020Model Serum Cups
Identity
- Trade Name
- Caplugs/Evergreen EUDAMEDFDA UDI
- Generic Name
- Culture tube FDA UDILaboratory analyser cuvette IVD, single-use FDA UDI
- Device Name
- Serum Cups EUDAMEDSterile 30 mL Freestanding w/Spork Centrifuge Tubes with Caps FDA UDI4 mL Serum Sample Cups FDA UDI
- Model / Reference
- 127-0017-020 EUDAMEDFDA UDISerum Cups EUDAMED222-3533-G8D FDA UDI
- Description
- Sterile 30 mL Freestanding w/Spork Centrifuge Tubes with Caps FDA UDI4 mL Serum Sample Cups FDA UDI
Identifiers
- Catalog Number
- 222-3533-G8D FDA UDI127-0017-020 FDA UDI
- Primary DI / UDI-DI
- 00810044206074 EUDAMEDFDA UDI00810044201154 FDA UDI
- Basic UDI-DI
- 081004420SCJX EUDAMED
- FDA Product Code
- NNI FDA UDIJCC FDA UDI
- EMDN Code
- W0503010280 SAMPLES ANALYSES, PLASTIC CONTAINERS - OTHER ACCESSORIES EUDAMED
- GMDN Term
- Culture tube FDA UDILaboratory analyser cuvette IVD, single-use FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.3250 FDA UDI864.4010 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Culture tube
Caplugs/Evergreen by Caplugs, Inc. — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Culture tube.
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- RTMED — Shandong Haidike Medical Products Co., Ltd. · Class I
- LabChoice Culture Tubes, With Dual Position Cap, Polystyrene, With Graduation — Dynarex Corp. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Caplugs, Inc.
Sources (3)
- FDA UDI 36a8d2c5-b0b8-4a2c-b0a5-2d075fa9fa35 35 fields · synced Jul 8, 2026
- FDA UDI d20b6c77-698f-4027-ba6c-e0e8f76ea81b 35 fields · synced May 30, 2026
- EUDAMED 9084bdab-90f2-4489-8edb-7a72d3e9f9be 61 fields · synced Jul 8, 2026