Identity
- Trade Name
- Eclipse FDA UDI
- Generic Name
- Blood pressure ambulatory recorder FDA UDI
- Model / Reference
- 98-0068-86 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10840935101154 FDA UDI
- 510(k) Number
- K003004 FDA UDI
- FDA Product Code
- DXN FDA UDI
- GMDN Term
- Blood pressure ambulatory recorder FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1130 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
Category: Blood pressure ambulatory recorder
Eclipse by Suntech Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Blood pressure ambulatory recorder.
- Microlife — MICROLIFE USA, INC. · Class II
- Welch Allyn — I.E.M. GmbH · Class II
- Mobil-O-Graph — I.E.M. GmbH · Class II
- Welch Allyn — I.E.M. GmbH · Class II
- Welch Allyn, Inc. — Welch Allyn, Inc. · Class II
- ABPM pro basic device — Somnomedics GmbH · Class II
- CONTEC — Contec Medical Systems Co., Ltd. · Class II
- ABPM cuff — I.E.M. GmbH · Class II
Cleared under the same submission
K003004 also covers:
- ri-cardio ABPM (24h BP device) w/cuffs for adults standard and large size — Rudolf Riester GmbH & Co. KG
- AccuWin — SUNTECH MEDICAL, INC.
- Eclipse — SUNTECH MEDICAL, INC.
- Eclipse — SUNTECH MEDICAL, INC.
- Eclipse — SUNTECH MEDICAL, INC.
- Eclipse — SUNTECH MEDICAL, INC.
- Eclipse — SUNTECH MEDICAL, INC.
- Eclipse — SUNTECH MEDICAL, INC.
- Eclipse — SUNTECH MEDICAL, INC.
- Eclipse — SUNTECH MEDICAL, INC.
- Eclipse — SUNTECH MEDICAL, INC.
- Eclipse — SUNTECH MEDICAL, INC.
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 |
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Manufacturer
- Manufacturer
- Suntech Medical, Inc.
Sources (1)
- FDA UDI 68cb5f05-21bf-49a5-8117-6656c1bffe39 34 fields · synced May 30, 2026