Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3035224824

FEI Number

3035224824

Entity Name

Opera Group Inc

City/State/Country

Newark, NJ, US

Establishment Address

972 Broad St Ste 300, Newark, NJ 07102, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Alpine HC Limited t/a Opera Beds (Owner Number: 10090592)

Owner / Operator Contact Address

Azure Hous, Connaught Road, Kingswood, Hull, GB-KHL HU7 3AP, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

BPL060-36O Solo Floor Bed - 105cm/3ft6 BPL061-30EUF1 Solo Comfort Bed - 90cm/3ft BPL061-36EUF1 Solo Comfort Bed - 105cm/3ft6 BPL063-30 Solo Safeside Floor Bed - 90cm/3ft BPL062US-36EOUF1 Solo Comfort Plus Bed US - 105cm/3ft6 BPL063-40 Solo Safeside Floor Bed - 120cm/4ft BPL035-40EOUF1 Signature Comfort Plus Profiling Bed - 120cm/4ft BPL063-36 Solo Safeside Floor Bed - 105cm/3ft6 BRB003 -60 Rotobed Change Rotating Dual Chair Bed - 180cm/6ft BPL033-40EUF1 Signature Comfort Profiling Bed - 120cm/4ft BPL060-30O Solo Floor Bed - 90cm/3ft BPL030 -30 Signature Profiling Bed - 90cm/3ft BPL062US-40EOUF1 Solo Comfort Plus Bed US - 120cm/4ft BPL033-36EUF1 Signature Comfort Profiling Bed - 105cm/3ft6 BPL035- 50EOUF1 Signature Comfort Plus Dual Profiling Bed - 150cm/5ft BPL033- 60EUF1 Signature Comfort Dual Profiling Bed - 180cm/6ft BRB002 -30AF Rotobed Free Rotating Chair Bed - 90cm/3ft BPL060-40O Solo Floor Bed - 120cm/4ft BPL030 -36 Signature Profiling Bed - 105cm/3ft6 BPL035- 60EOUF1 Signature Comfort Plus Dual Profiling Bed - 180cm/6ft BPL030 -40 Signature Profiling Bed - 120cm/4ft BPL002US-WSR Classic Home Hospital Bed with Rails BPL035-30EOUF1 Signature Comfort Plus Profiling Bed - 90cm/3ft BPL062US-30EOUF1 Solo Comfort Plus Bed US - 90cm/3ft BPL033-30EUF1 Signature Comfort Profiling Bed - 90cm/3ft BPL061-40EUF1 Solo Comfort Bed - 120cm/4ft BRB001 -36WDAF Rotobed Home Rotating Chair Bed - 105cm/3ft6 BRB001 -30WDAF Rotobed Home Rotating Chair Bed - 90cm/3ft BPL050-40 Signature Bariatric Profiling Bed - 120cm/4ft BPL033- 50EUF1 Signature Comfort Dual Profiling Bed - 150cm/5ft BPL035-36EOUF1 Signature Comfort Plus Profiling Bed - 105cm/3ft6 BRB003 -36 Rotobed Change Rotating Chair Bed - 105cm/3ft6 BRB002 -36AF Rotobed Free Rotating Chair Bed - 105cm/3ft6 BRB003 -30 Rotobed Change Rotating Chair Bed - 90cm/3ft BPL002US-W Classic Home Hospital Bed BOA130-W 3 Part Split Side Rail - Walnut (3 pieces = 1 side) MSM036 Ultimate Very High Risk Profiling Mattress - 120cm/4ft MSM036 Ultimate Very High Risk Profiling Mattress - 90cm/3ft BRM001 RotoBed Safesleep Mattress - 90cm/3ft MSM036 Ultimate Very High Risk Profiling Mattress BRM002 RotoBed Bariasleep Mattress - 105cm/3ft6 MSM056 Ultimate 105cm Very High Risk Profiling Mattress BRM005 Rotobed Airsleep Wide Mattress - 105cm/3ft6 MSM057 Ultimate 120cm Very High Risk Profiling Mattress BRM004 RotoBed Roho Dry Flotation Air Mattress - 90cm/3ft MSM036 Ultimate Very High Risk Profiling Mattress - 105cm/3ft6 BRM007 Rotobed Airsleep Mattress - 90cm/3ft

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FNL	Bed, Ac-Powered Adjustable Hospital	General Hospital	Class 2	880.5100	2024-04-24
IKY	Mattress, Flotation Therapy, Non-Powered	General Hospital	Class 1	880.5150	2024-04-17

Official Correspondent

Mindy McCann

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Alpine HC Limited t/a Opera Beds

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3030979168	ALPINE HC LIMITED T/A OPERA BEDS	Hull Kingston upon Hull, City of, GB

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K935837	Healthcare Designs	AIRHYTHM HEALTHCARE BED	1994-06-21

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0016-2007	Sunrise Medical CCG, Inc.	2	Joerns Ultra Care 770 Model AC Powered Beds with model numbers U770, U770 AL , U770 GNDAL. Sunrise Medical, Long Term Care Division, 5001 Joerns Drive, Stevens Point, WI 54481 USA.
Z-0017-2007	Hill-Rom, Inc.	2	Hill-Rom VersaCare Hospital Bed with optional patient pendant P3207A01 or P3207A02; model P3200.
Z-0019-2015	Arjo Hospital Equipment AB Verkstadsvagen	2	ArjoHuntleigh Contoura C1000 series beds are designed to accommodate patients weighing up to 990 lbs. (450 kg). Model C1000 is the basic bed. Model C1080 includes a weighing system and a power outlet for an ArjoHuntleigh approved mattress pump. Product Usage: The Contoura series bariatric beds are electrically operating medical beds with a maximum patient weight of 450 kg. This range is intended for use in hospitals to facilitate management of obese patients. An optional integrated weighing system helps with assessment and management of the patient if required.
Z-0026-2007	Extended Care Air Therapy Systems Inc	2	ECAT (Extended Care Air Therapy Systems) 2000 Safe Enclosure Bed

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3035224824. Last updated year: 2026. Please use registration number 3035224824 when referencing this establishment in official correspondence.