# Paraid Hcg-M04

> Active: European Union and United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/paraid-hcg-m04>
- Manufacturer: [Nantong Egens Biology Technic Co., Ltd.](https://devicerts.com/manufacturers/nantong-egens-biology-technic-co-ltd) (FDA registration: United States)
- Name in the registry: PARAID HCG-M04
- Device class: Class B (EU IVDR); Class II (US FDA)
- FDA product code: LCX
- EMDN: W0102160302 HCG - RT & POC
- GMDN: Human chorionic gonadotropin alpha-subunit IVD, calibrator (43774)

## Registrations and authorizations

- **EUDAMED** · CE/IVDR · European Union · Basic UDI-DI 69375799yszy03G4 · UDI-DI 06937579912370 · registered 2026-05-09 · status: Active
- **GUDID** · GUDID listing · United States · UDI-DI 06937579912370 · listed 2023-08-11 · status: Listed (GUDID: in commercial distribution)
- **GUDID** · FDA 510(k) · United States · K123050 · decision 2013-02-05 · decision SESE · status: Active · from GUDID

## EU certificates

- V76 063367 0023 · Technical documentation · IVDR · notified body TÜV SÜD Product Service GmbH · issued 2025-09-18 · expires 2030-09-17 · status: issued

## Recalls

No recall on record.

## Identity

- Trade name: Early Pregnancy Test [EUDAMED]; PARAID [FDA GUDID (AccessGUDID)]
- Generic name: Human chorionic gonadotropin alpha-subunit IVD, calibrator [FDA GUDID (AccessGUDID)]
- Model / reference: HE01E0201 [EUDAMED]; HCG-M04 [FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: 06937579912370 [EUDAMED, FDA GUDID (AccessGUDID)]
- Basic UDI-DI: 69375799yszy03G4 [EUDAMED]
- 510(k) Number: K123050 [FDA GUDID (AccessGUDID)]
- FDA product code: LCX [FDA GUDID (AccessGUDID)]
- EMDN code: W0102160302 [EUDAMED]
- GMDN term: Human chorionic gonadotropin alpha-subunit IVD, calibrator (43774) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class B [EUDAMED]; Class II [FDA GUDID (AccessGUDID)]
- Regulation number: 862.1155 [FDA GUDID (AccessGUDID)]
- EU registration type: Standard device [EUDAMED]
- EU market of registration: Poland [EUDAMED]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Properties

- Single use: Yes [FDA GUDID (AccessGUDID)]
- Self-testing: Yes [EUDAMED]
- Professional testing: Yes [EUDAMED]
- New device: Yes [EUDAMED]
- Lot / batch number: Yes [FDA GUDID (AccessGUDID)]
- Expiration date: Yes [FDA GUDID (AccessGUDID)]
- Supplied sterile: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Sterilise before use: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Implantable: No [FDA GUDID (AccessGUDID)]
- Contains latex: No [FDA GUDID (AccessGUDID)]
- Contains human tissues or cells: No [EUDAMED]
- Contains animal tissues or cells: No [EUDAMED]
- Contains substances of microbial origin: No [EUDAMED]
- Reagent: No [EUDAMED]
- IVD kit: No [EUDAMED]
- Near-patient testing: No [EUDAMED]
- Companion diagnostics: No [EUDAMED]
- IVD instrument: No [EUDAMED]
- Prescription use: No [FDA GUDID (AccessGUDID)]
- Over-the-counter: No [FDA GUDID (AccessGUDID)]
- Convenience kit: No [FDA GUDID (AccessGUDID)]
- Combination product: No [FDA GUDID (AccessGUDID)]
- HCT/P: No [FDA GUDID (AccessGUDID)]
- Premarket exempt: No [FDA GUDID (AccessGUDID)]
- Serial number: No [FDA GUDID (AccessGUDID)]
- Manufacturing date: No [FDA GUDID (AccessGUDID)]

## Source and citation

- Cite as: Paraid Hcg-M04, Nantong Egens Biology Technic Co., Ltd. deviCERTS medical device catalogue. https://devicerts.com/devices/paraid-hcg-m04 (data as of 2026-11-14).
- Data sources: [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/), [EUDAMED](https://ec.europa.eu/tools/eudamed)
- Registry records last synced: 2026-11-07
- Statuses computed as of: 2026-11-14
- JSON: <https://devicerts.com/devices/paraid-hcg-m04.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/paraid-hcg-m04
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.