Identity
- Trade Name
- Disposable Urine Collection Tube EUDAMEDGongdong FDA UDI
- Generic Name
- Evacuated urine specimen container IVD, preservative FDA UDI
- Device Name
- Disposable Urine Collection Tube EUDAMEDDisposable urine collection tube, Additive is boric acid, specification 16×100 PET 8ml FDA UDI
- Model / Reference
- GD080UB EUDAMEDFDA UDIboric acid EUDAMED
- Description
- Disposable urine collection tube, Additive is boric acid, specification 16×100 PET 8ml FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06947462433202 EUDAMED16947462494309 FDA UDI
- Basic UDI-DI
- 6947462411111166M7 EUDAMED
- FDA Product Code
- JSM FDA UDI
- EMDN Code
- W05010202 URINE COLLECTION, TUBES EUDAMED
- GMDN Term
- Evacuated urine specimen container IVD, preservative FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 866.2390 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
No
Microbial Substances
No
Reagent
No
Self Testing
No
Near-Patient Testing
No
Professional Testing
No
Companion Diagnostics
No
Surgical Instrument
No
New Device
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
Yes
Expiration Date
Yes
Manufacturing Date
Yes
Category: Evacuated urine specimen container IVD, preservative
Gongdong by Zhejiang Gongdong Medical Technology Co., Ltd., — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Evacuated urine specimen container IVD, preservative.
- V-Monovette®Urine 10ml bo.acid — Sarstedt Aktiengesellschaft & Co.KG · Class I
- BD Vacutainer® Urinalysis Transfer Straw Kit — BECTON DICKINSON AND COMPANY · Class I
- BD Vacutainer® C&S Cup Kit — BECTON DICKINSON AND COMPANY · Class I
- V-Monovette® Urine 4ml bo.acid — Sarstedt Aktiengesellschaft & Co.KG · Class I
- Vacuette — Greiner Bio-One GmbH · Class I
- BD Vacutainer® Urine Complete Cup Kit — BECTON DICKINSON AND COMPANY · Class I
- BD Vacutainer® C&S Boric Acid Kit — BECTON DICKINSON AND COMPANY · Class I
- BD Vacutainer® C&S Preservative Urine Tube — BECTON DICKINSON AND COMPANY · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDR
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
- Zhejiang Gongdong Medical Technology Co., Ltd.,
Sources (2)
- FDA UDI 152f2d6c-b50c-4bd5-b2a2-4190d55ebc5d 33 fields · synced Jun 18, 2026
- EUDAMED 5e475dc1-46d1-40d3-8fa8-f1a2470ad4b2 61 fields · synced Jun 18, 2026