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Fapha1000

EUDAMEDFDA UDI

Class I (EU MDR)

Ref FAPHA1000Model FA3500

by Helping Hand Company (Ledbury) Ltd

Identity

Trade Name
FAPHA1000 EUDAMED
ACHEEVA TABLET HOLDER FDA UDI
Generic Name
Bed mattress support platform, electric FDA UDI
Device Name
SYMMKIT ACHEEVA JNR STARTER SUPPORT PACK EUDAMED
ACHEEVA TABLET HOLDER FDA UDI
Model / Reference
FA3500 EUDAMED
FAPHA1000 EUDAMED
ACHEEVA TABLET HOLDER FDA UDI
Description
ACHEEVA TABLET HOLDER FDA UDI

Identifiers

Catalog Number
FAPHA1000 FDA UDI
Primary DI / UDI-DI
05050962361911 EUDAMEDFDA UDI
Basic UDI-DI
5050962ACHEEVAPKX2 EUDAMED
FDA Product Code
LLI FDA UDI
EMDN Code
V080302 PATIENT POSITIONING MEDICAL CUSHIONS EUDAMED
GMDN Term
Bed mattress support platform, electric FDA UDI

Classification

Device Class
Class I EUDAMED
Class II FDA UDI
Regulation Number
880.5100 FDA UDI
Medical Purpose
TP PROVIDE TARGETED SUPPORT FOR THE USER EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

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

No

FDA UDI

Manufacturing Date

No

FDA UDI

Fapha1000 by Helping Hand Company (Ledbury) Ltd — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Helping Hand Company (Ledbury) Ltd
EUDAMED SRN
UK-PR-000052099

Sources (2)

  • EUDAMED 1e91e538-611d-47cc-bcd4-0d21492d736f 61 fields · synced Jul 18, 2026
  • FDA UDI 27391f97-333b-410c-a8ae-44ab9b02aad9 35 fields · synced May 30, 2026