Notified Body · No. 2233

CE Certification for Personal Protective Equipment (PPE)

Notified Body No. 2233 under Regulation (EU) 2016/425.

Obligation

Placing Category III PPE on the market requires EU type-examination and certification (Module B + C2/D).

Risk

Without certification the product cannot lawfully be placed on the EU market.

Our solution

As a notified body (NB 2233) we run the type-examination and production surveillance, with accredited-lab backing.

What you receive

GÉPTESZT provides independent conformity assessment services for PPE manufacturers worldwide.

We are designated to perform

Our activities focus on high-risk PPE in Category III, where compliance with essential health and safety requirements is critical for EU market access. We support our certification work with our in-house ISO/IEC 17025-accredited laboratory, and where needed, collaborate with other accredited laboratories to ensure timely and comprehensive testing.

We certify PPE used for

Modules C2 and D – Production monitoring

For manufacturers of Category III PPE, we perform:

We are also authorized to carry out production surveillance for Category III safety footwear and protective gloves, in addition to the listed PPE types. By involving our local auditors in production surveillance, we are able to keep travel-related costs at a low level.

Conformity assessment modules under Regulation (EU) 2016/425

The route to CE marking depends on the PPE risk category. For Categories II and III a notified body — GÉPTESZT (NB 2233) — must be involved; for Category III, throughout production.

Category I Low risk

E.g. superficial mechanical injury, mild cleaning agents — gardening gloves, sunglasses.

AInternal production control

The manufacturer ensures and declares conformity itself. (Annex IV)

No notified body required.

Category II Intermediate risk

Everything not in Category I or III — e.g. general protective gloves, high-visibility clothing.

BEU type-examination

A notified body examines and certifies the technical design. (Annex V)

CConformity to type

The manufacturer ensures series production conforms to the type (internal production control). (Annex VI)

Category III Serious / irreversible

E.g. fall protection, respiratory, chemical and high-voltage risks — GÉPTESZT's core area.

BEU type-examination

Examination and certification of the technical design. (Annex V)

Production surveillance — one module

C2Supervised product checks

At random intervals, by a notified body. (Annex VII)

or
DQuality assurance of production

Assessment and surveillance of the manufacturer's quality management system. (Annex VIII)

Notified body — GÉPTESZT (NB 2233) Manufacturer

As notified body NB 2233, GÉPTESZT performs Module B (EU type-examination) and the Category III production modules (C2 and D).

2009

Notified Body since

200+

manufacturers supported

~40

countries

Since obtaining our Notified Body status in 2009, we have supported over 200 manufacturers across nearly 40 countries, helping them to successfully place PPE on the European market with confidence.

For verification of our notification, see the NANDO database.

Legal background

Links point to the current official text; the Hungarian decrees are available in Hungarian only.