Identity
- Trade Name
- Isiris™ Monitor FDA UDI
- Generic Name
- Endoscopic video image display unit FDA UDI
- Device Name
- Isiris Monitor FDA UDI
- Model / Reference
- MN0001 FDA UDI
- Description
- Isiris Monitor FDA UDI
Identifiers
- Catalog Number
- MN0001 FDA UDI
- Primary DI / UDI-DI
- 05707480136032 FDA UDI
- FDA Product Code
- FAJ FDA UDI
- GMDN Term
- Endoscopic video image display unit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Height — 175 Millimeter FDA UDIWidth — 241 Millimeter FDA UDIWeight — 1500 Gram FDA UDI
Category: Endoscopic video image display unit
Isiris™ Monitor by Ambu A/S — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endoscopic video image display unit.
- Insighters — Shenzhen Insighters Medical Technology Co., Ltd. · Class I
- CuratOR — EIZO CORPORATION · Class I
- NDS — PENTAX of America, Inc. · Class I
- Insighters — Shenzhen Insighters Medical Technology Co., Ltd. · Class I
- CuratOR — EIZO CORPORATION · Class I
- Karl Storz — EIZO CORPORATION · Class I
- AESCULAP — AESCULAP, INC. · Class I
- Insighters — Shenzhen Insighters Medical Technology Co., Ltd. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ambu A/S
Sources (1)
- FDA UDI fda210a7-f539-45cc-b04a-b56385e6ee2b 37 fields · synced May 30, 2026