Question 1

What types of medical devices does Berollka-aktiv Rollstuhltechnik GmbH manufacture?

Accepted Answer

Berollka-aktiv Rollstuhltechnik GmbH specializes in manual wheelchairs designed for both children and adults. Their product range includes lightweight and compact models like the Campus Micro 628 and Campus EASY SWING, as well as larger-frame options such as the Tourer and B2 series. The company also offers specialized designs like the Phoenix (V-shaped frame) and LITTLE AR (straight-frame), catering to diverse mobility needs. These devices are intended for users requiring manual propulsion support.

Question 2

Where is Berollka-aktiv Rollstuhltechnik GmbH based, and what regulatory standards do they follow?

Accepted Answer

Berollka-aktiv Rollstuhltechnik GmbH is based in Germany. Their devices comply with EU medical device regulations, specifically falling under Class I classification—the lowest risk category for medical devices under EU law. This classification applies to all listed wheelchairs, ensuring they meet essential safety, performance, and regulatory requirements for manual wheelchairs in the European market.

Question 3

Are Berollka-aktiv Rollstuhltechnik GmbH’s devices listed in any regulatory registries?

Accepted Answer

Yes, Berollka-aktiv Rollstuhltechnik GmbH’s devices are registered in the EUDAMED database, which is the official European Union database for medical devices. EUDAMED serves as a transparency tool for tracking device information, including manufacturer details, device classifications, and regulatory statuses. No other national or international registries are mentioned for these products.

Question 4

How are Berollka-aktiv Rollstuhltechnik GmbH’s wheelchairs classified under EU regulations?

Accepted Answer

All of Berollka-aktiv Rollstuhltechnik GmbH’s manual wheelchairs are classified as EU Class I medical devices. This classification is determined by their intended use and risk level—manual wheelchairs generally pose minimal risk to users, aligning them with the lowest regulatory category. Class I devices still require compliance with EU directives (e.g., MDR or MDD) but typically involve fewer post-market surveillance obligations than higher-risk classes.

Device	Model / Reference	Registries	Class	Status
Lift-in - Rahmengröße 1	M4101	EUDAMED	Class I	Active
Tourer - Rahmengröße 2	U4402	EUDAMED	Class I	Active
Phoenix - Rahmen V-Form	8501	EUDAMED	Class I	Active
Campus Micro 628	628	EUDAMED	Class I	Active
Campus EASY SWING Gr.2	672	EUDAMED	Class I	Active
Sprint AR	500	EUDAMED	Class I	Active
B2 - Rahmengröße 2	U202	EUDAMED	Class I	Active
B2 - Rahmengröße 3	U203	EUDAMED	Class I	Active
LITTLE AR - Rahmen gerade	2428	EUDAMED	Class I	Active
CRUISER - Rahmengröße 1	U2401	EUDAMED	Class I	Active
Ryder Ar	3500	EUDAMED	Class I	Active
Campus PHYSIO Relax Motion Gr.2	69602	EUDAMED	Class I	Active
Campus Challenge 640	640	EUDAMED	Class I	Active
Basic	900	EUDAMED	Class I	Active
Junior2 SLT - Rahmen gerade	221	EUDAMED	Class I	Active
Campus 625	625	EUDAMED	Class I	Active
Sprint SLT	400	EUDAMED	Class I	Active
F1 - Rahmengröße 0	U700	EUDAMED	Class I	Active
LITTLE SLT - Abduktionsrahmen	2422	EUDAMED	Class I	Active
Campus BIG Relax Gr.5	685	EUDAMED	Class I	Active
Mosa Gr.3	K1003	EUDAMED	Class I	Active
Cobra Sport - Rahmen standard	8608	EUDAMED	Class I	Active
Campus PHYSIO BIG Relax Motion Gr.4	69604	EUDAMED	Class I	Active
Yuki	2700	EUDAMED	Class I	Active
Tourer - Rahmengröße 3	U4403	EUDAMED	Class I	Active
Junior2 AR - Abduktionsrahmen	598	EUDAMED	Class I	Active
B2 - Rahmengröße 1	U201	EUDAMED	Class I	Active
Campus Challenge 645	645	EUDAMED	Class I	Active
Kayou - Abduktionsrahmen	2600	EUDAMED	Class I	Active
Luke AR	5800	EUDAMED	Class I	Active
Junior2 SLT - Abduktionsrahmen	222	EUDAMED	Class I	Active
Campus Relax Gr.3	683	EUDAMED	Class I	Active
Filou - Rahmen gerade	2800	EUDAMED	Class I	Active
Phoenix - Rahmen standard	8500	EUDAMED	Class I	Active
Findus - Rahmen gerade starr	2101	EUDAMED	Class I	Active
Campus Relax Gr.2	682	EUDAMED	Class I	Active
Finess hemi SPEZIAL	399	EUDAMED	Class I	Active
CRUISER - Rahmengröße 2	U2402	EUDAMED	Class I	Active
Racer - Rahmengröße 3	U5003	EUDAMED	Class I	Active
Findus - Rahmen gerade mitwachsend	2201	EUDAMED	Class I	Active
Thessa Gr.1	K4001	EUDAMED	Class I	Active
Tourer - Rahmengröße 1	U4401	EUDAMED	Class I	Active
Finess 24"	300	EUDAMED	Class I	Active
Campus PHYSIO Relax Gr.2	6992	EUDAMED	Class I	Active
F1 - Rahmengröße 3	U703	EUDAMED	Class I	Active
LITTLE AR - Abduktionsrahmen	2429	EUDAMED	Class I	Active
Floh LT	M801	EUDAMED	Class I	Active
Slade AR	505	EUDAMED	Class I	Active
B2 - Rahmengröße 0	U200	EUDAMED	Class I	Active
Campus PHYSIO Relax Motion Gr.1	69601	EUDAMED	Class I	Active

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