Identity
- Trade Name
- andorate® 2-piece Cleaning Adapter Kit FDA UDI
- Generic Name
- Surgical instrument/endoscope cleaning utensil, single-use FDA UDI
- Model / Reference
- GAR3875 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04897106953813 FDA UDI
- FDA Product Code
- FFY FDA UDI
- GMDN Term
- Surgical instrument/endoscope cleaning utensil, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Surgical instrument/endoscope cleaning utensil, single-use
andorate® 2-piece Cleaning Adapter Kit by GA Health Company Limited — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Surgical instrument/endoscope cleaning utensil, single-use.
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- Cleaning Brushes for Endoscope — Changzhou Jiuhong Medical Instrument Co., Ltd. · Class I
- Cleaning Brushes — ZHEJIANG CHUANGXIANG MEDICAL TECHNOLOGY CO., LTD. · Class I
- Cleaning brush — H.+H. Maslanka Chirurgische Instrumente GmbH · Class I
- Cleaning brush — H.+H. Maslanka Chirurgische Instrumente GmbH · Class I
- Cleaning brushes — SANDERSON MACLEOD · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- GA Health Company Limited
Sources (2)
- FDA UDI 0dceffc8-3452-4139-8b07-5150299ca746 32 fields · synced Jun 17, 2026
- EUDAMED 1 fields · synced Jun 2, 2026