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Intigena GmbH & Co.KG.

Germany DE-MF-000004948 Last updated 17 Sep 2026

Devices
103
Registries
EUDAMED
FDA recalls
0

Catalogue103

Page 1 of 3

  • Sana Ref 04013209001637

    Class I EUDAMED Active

  • Sana Ref 04013209001651

    Class I EUDAMED Active

  • Satessa Diskret Ref 04013209001613

    Class I EUDAMED Active

  • Sana Ref 04013209001668

    Class I EUDAMED Active

  • Sana Ref 04013209001644

    Class I EUDAMED Active

  • Satessa discreet Ref 04013209001576

    Class I EUDAMED Active

  • Sana Ref 04013209001699

    Class I EUDAMED Active

  • Satessa Discreet Ref 04013209001583

    Class I EUDAMED Active

  • Sana Ref 04013209001675

    Class I EUDAMED Active

  • Satessa discreet Ref 04013209001606

    Class I EUDAMED Active

  • Sana Ref 04013209001620

    Class I EUDAMED Active

  • Satessa discreet Ref 04013209001590

    Class I EUDAMED Active

  • Sana Ref 04013209001682

    Class I EUDAMED Active

  • Clever Ref 04013209001071

    Class I EUDAMED Active

  • Satessa Ref 04013209000913

    Class I EUDAMED Active

  • BiComfort Ref 04013209000388

    Class I EUDAMED Active

  • Satessa discreet Ref 04013209001248

    Class I EUDAMED Active

  • Satessa Ref 04013209000227

    Class I EUDAMED Active

  • Satessa Ref 04013209000142

    Class I EUDAMED Active

  • Sana Ref 04013209000043

    Class I EUDAMED Active

  • Satessa Ref 04013209000920

    Class I EUDAMED Active

  • BiComfort Ref 04013209000357

    Class I EUDAMED Active

  • Today discreet Ref 04013209001026

    Class I EUDAMED Active

  • Satessa Ref 04013209001057

    Class I EUDAMED Active

  • Siempre Discreet Ref 04013209001552

    Class I EUDAMED Active

  • Satessa Ref 04013209000210

    Class I EUDAMED Active

  • Loft Ref 04013209000197

    Class I EUDAMED Active

  • Satessa Ref 04013209000258

    Class I EUDAMED Active

  • Satessa discreet Ref 04013209001095

    Class I EUDAMED Active

  • BiComfort Ref 04013209000395

    Class I EUDAMED Active

  • Sana Ref 04013209000029

    Class I EUDAMED Active

  • Secure Ref 04013209001330

    Class I EUDAMED Active

  • Today discreet Ref 04013209000975

    Class I EUDAMED Active

  • Satessa discreet Ref 04013209001156

    Class I EUDAMED Active

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    Class I EUDAMED Active

  • Secure Ref 04013209001354

    Class I EUDAMED Active

  • Secure Ref 04013209001361

    Class I EUDAMED Active

  • Satessa discreet Ref 04013209001118

    Class I EUDAMED Active

  • Satessa discreet Ref 04013209001149

    Class I EUDAMED Active

  • BiComfort Ref 04013209000340

    Class I EUDAMED Active

  • Royal Excellence Ref 04013209000616

    Class I EUDAMED Active

  • Today discreet Ref 04013209001033

    Class I EUDAMED Active

  • Loft Ref 04013209000067

    Class I EUDAMED Active

  • Inea Ref 04013209000944

    Class I EUDAMED Active

  • Satessa discreet Ref 04013209001477

    Class I EUDAMED Active

  • Loft Ref 04013209000173

    Class I EUDAMED Active

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    Class I EUDAMED Active

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  • Clever Ref 04013209000463

    Class I EUDAMED Active

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What Intigena GmbH & Co.KG. makes

Intigena produces a range of Class I medical devices primarily focused on incontinence management, including absorbent pads and protective underwear designed for discreet use. Their portfolio also includes wound care products like adhesive dressings and wound contact layers, as well as incontinence-related accessories such as protective sheets and bed pads.

All devices are listed under the EU Medical Device Regulation (MDR) in the euDAMED database as Class I products. The company is based in Germany and adheres to EU regulatory requirements for these non-invasive, low-risk devices.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Intigena GmbH & Co.KG. manufacture?

Intigena GmbH & Co.KG. specializes in Class I medical devices, primarily focused on incontinence management and wound care. Their product range includes absorbent pads, protective underwear for discreet use, adhesive dressings, wound contact layers, and incontinence accessories like protective sheets and bed pads. These devices are designed to address common, low-risk medical needs without invasive procedures.

Where is Intigena GmbH & Co.KG. based, and how does this affect its regulatory compliance?

Intigena GmbH & Co.KG. is based in Germany, which places its devices under the jurisdiction of the EU Medical Device Regulation (MDR). Since all its products fall under Class I—considered low-risk—they must comply with MDR requirements, including mandatory registration in the EU’s central database, euDAMED. This ensures transparency and traceability for regulatory oversight.

Which regulatory registries list Intigena’s medical devices, and why?

Intigena’s devices are listed in euDAMED, the European Union’s central database for medical devices. This registry is required under the MDR for all Class I products, ensuring they meet EU safety and performance standards. Listing in euDAMED is mandatory for market placement in the EU, as it verifies compliance and provides authorities with accessible device information.

How are Intigena’s devices classified under EU regulations, and what does this mean for users?

Intigena’s devices are classified as Class I under the EU MDR, indicating they pose minimal risk to users. This classification applies to products like absorbent pads, protective underwear, and wound care items, which are non-invasive and typically used for short-term or low-risk applications. Class I devices undergo basic conformity assessments but do not require clinical trials, as their safety and performance are deemed low-risk.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
Germany(from SRN)
Address
2, Steineshoffweg, Mülheim an der Ruhr, Germany
Website
intigena.com
PRRC contact
Thomas Rosa
EUDAMED SRN
DE-MF-000004948