Identity
- Trade Name
- AFCS PEARLS™ Bed unit FDA UDI
- Generic Name
- Air-fluidized bed FDA UDI
- Device Name
- Air-Fluidized bed - see www.synergiecare.com AFCS PEARLS™ (SAT2) Innovative care Bed/Frame FDA UDI
- Model / Reference
- SAT2 FDA UDI
- Description
- Air-Fluidized bed - see www.synergiecare.com AFCS PEARLS™ (SAT2) Innovative care Bed/Frame FDA UDI
Identifiers
- Catalog Number
- 2010003-US FDA UDI
- Primary DI / UDI-DI
- 08720387388011 FDA UDI
- FDA Product Code
- INX FDA UDI
- GMDN Term
- Air-fluidized bed FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5160 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
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Air-fluidized bed
AFCS PEARLS™ Bed unit by Synergie Nederland B.V. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Air-fluidized bed.
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- AFCS PEARLS™ Air filter — Synergie Nederland B.V. · Class II
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- AFCS PEARLS™ & SANDS™ Corner clamps — Synergie Nederland B.V. · Class II
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 II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Synergie Nederland B.V.
Sources (2)
- FDA UDI 8a6f6b01-6840-4fba-9ec2-4976a1bcaf9f 34 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 4, 2026