Identity
- Trade Name
- All-in-One Health Monitor FDA UDI
- Generic Name
- Multiple physiological parameter spot-check system, clinical FDA UDI
- Device Name
- Spot-Check Monitor EUDAMED
- Model / Reference
- PC-303 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06941900601918 EUDAMED06941900603523 FDA UDI
- Basic UDI-DI
- 69419006PC303018N EUDAMED
- Direct Marketing DI
- 06941900601918 EUDAMED
- 510(k) Number
- K170047 FDA UDI
- FDA Product Code
- DSH FDA UDINBW FDA UDIFLL FDA UDIDQA FDA UDIDXN FDA UDIMWI FDA UDI
- EMDN Code
- Z1203020202 TRANSPORTABLE/PORTABLE MULTI–PARAMETER PATIENT MONITORS EUDAMED
- GMDN Term
- Multiple physiological parameter spot-check system, clinical FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2800 FDA UDI862.1345 FDA UDI880.2910 FDA UDI870.2700 FDA UDI870.1130 FDA UDI870.2300 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
Yes
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Multiple physiological parameter spot-check system, clinical
All-in-One Health Monitor by Shenzhen Creative Industry Co., Ltd. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
K170047 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Shenzhen Creative Industry Co., Ltd.
Sources (2)
- FDA UDI 8768ba04-6b83-4e12-aae6-46042f949895 33 fields · synced Jun 11, 2026
- EUDAMED 7758b74b-c2a6-4da0-90dc-162965fd4ae6 61 fields · synced Jun 11, 2026