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Sign in to claim this brandEuropapa Handels GmbH
US
Last updated May 23, 2026
What Europapa Handels GmbH makes
Europapa Handels GmbH manufactures nitrile examination and treatment gloves that are non-powdered and non-antimicrobial. These gloves are designed for medical and clinical use, ensuring barrier protection during procedures requiring sterile or clean hand hygiene.
The company’s products fall under FDA’s Class I device classification and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer is based in the United States.
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 Europapa Handels GmbH manufacture?
Europapa Handels GmbH specializes in nitrile examination and treatment gloves that are non-powdered and non-antimicrobial. These gloves are specifically designed for medical and clinical applications, providing a barrier to protect against contamination during procedures where sterile or clean hand hygiene is required.
Where is Europapa Handels GmbH based?
Europapa Handels GmbH is based in the United States. The company’s location is relevant for understanding its regulatory and operational context, particularly when navigating device compliance and distribution within the US market.
How are Europapa Handels GmbH’s devices classified by the FDA?
The devices manufactured by Europapa Handels GmbH fall under the FDA’s Class I classification. This classification is typically assigned to low-risk medical devices that pose minimal potential harm to users, such as certain personal protective equipment like nitrile gloves. Class I devices often require less stringent regulatory oversight compared to higher-risk categories.
Are Europapa Handels GmbH’s devices listed in any regulatory databases?
Yes, Europapa Handels GmbH’s devices are included in the FDA’s Unique Device Identifier (UDI) database. The UDI system helps ensure traceability and transparency in the medical device supply chain, allowing regulators, healthcare providers, and patients to identify and track specific devices throughout their lifecycle.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 342733760
Catalogue (80)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Europapa | 80353 | FDA UDI | Class I | Active |
| Europapa | 80133 | FDA UDI | Class I | Active |
| Europapa | 80447 | FDA UDI | Class I | Active |
| Europapa | 80131 | FDA UDI | Class I | Active |
| Europapa | 80351 | FDA UDI | Class I | Active |
| Europapa | 80378 | FDA UDI | Class I | Active |
| Europapa | 80446 | FDA UDI | Class I | Active |
| Europapa | 80360 | FDA UDI | Class I | Active |
| Europapa | 80443 | FDA UDI | Class I | Active |
| Europapa | 80093 | FDA UDI | Class I | Active |
| Europapa | 80369 | FDA UDI | Class I | Active |
| Europapa | 80089 | FDA UDI | Class I | Active |
| Europapa | 80365 | FDA UDI | Class I | Active |
| Europapa | 80171 | FDA UDI | Class I | Active |
| Europapa | 80207 | FDA UDI | Class I | Active |
| Europapa | 80168 | FDA UDI | Class I | Active |
| Europapa | 80092 | FDA UDI | Class I | Active |
| Europapa | 80366 | FDA UDI | Class I | Active |
| Europapa | 80354 | FDA UDI | Class I | Active |
| Europapa | 80208 | FDA UDI | Class I | Active |
| Europapa | 80347 | FDA UDI | Class I | Active |
| Europapa | 80216 | FDA UDI | Class I | Active |
| Europapa | 80348 | FDA UDI | Class I | Active |
| Europapa | 80374 | FDA UDI | Class I | Active |
| Europapa | 80370 | FDA UDI | Class I | Active |
| Europapa | 80359 | FDA UDI | Class I | Active |
| Europapa | 80202 | FDA UDI | Class I | Active |
| Europapa | 80363 | FDA UDI | Class I | Active |
| Europapa | 80375 | FDA UDI | Class I | Active |
| Europapa | 80039 | FDA UDI | Class I | Active |
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