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Henke-Sass, Wolf GmbH

Germany·DE-MF-000005531

Last updated May 24, 2026

What Henke-Sass, Wolf GmbH makes

Henke-Sass, Wolf GmbH manufactures single-use hypodermic needles, general-purpose syringes, metered-delivery hypodermic syringes, insulin syringes with needles, irrigation syringes, ear canal irrigation syringes, and reusable dental anaesthesia syringes. The company also produces rigid optical laparoscopes for minimally invasive surgical procedures.

The devices in the portfolio are classified as Class I and Class II medical devices and are listed in the FDA’s Global Unique Device Identification Database (GUDID). The company is based in Germany.

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

Frequently asked questions

What does Henke-Sass, Wolf GmbH manufacture?

Henke-Sass, Wolf GmbH manufactures single-use hypodermic needles, general-purpose syringes, metered-delivery hypodermic syringes, insulin syringes with needles, irrigation syringes, ear canal irrigation syringes, reusable dental anaesthesia syringes, and rigid optical laparoscopes for minimally invasive surgical procedures.

Where is Henke-Sass, Wolf GmbH based?

Henke-Sass, Wolf GmbH is based in Germany, as indicated by the country code DE in the device data.

Which regulatory registries list Henke-Sass, Wolf GmbH's devices?

Henke-Sass, Wolf GmbH's devices are listed in the FDA’s Global Unique Device Identification Database (GUDID), referenced in the data as fda_udi.

How are Henke-Sass, Wolf GmbH's devices classified?

The devices manufactured by Henke-Sass, Wolf GmbH are classified as Class I and Class II medical devices, according to the device classes specified in the data.

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

Information

Country: Germany
Address: 1, Keltenstrasse, Tuttlingen, Germany
Website: www.henkesasswolf.de
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 074629466473
PRRC Contact: Simon Aichele
EUDAMED SRN: DE-MF-000005531
FDA FEI Number: —
DUNS Number: 317326411

Catalogue (537)

Page 8 of 11

Device	Model / Reference	Registries	Class	Status
Hsw Fine-Ject®	8300022134	FDA UDI	Class II	Active
Hsw Henke-Ject®	5022L000V0	FDA UDI	Class II	Active
Hsw Soft-Ject®	5100.000V0	FDA UDI	Class II	Active
Hsw Norm-Ject®	4102H000V0	FDA UDI	Class II	Active
Hsw Norm-Ject®	40127200V0	FDA UDI	Class II	Active
Hsw Henke-Ject®	4710009025	FDA UDI	Class II	Active
Hsw Soft-Ject®	5022S000V0	FDA UDI	Class II	Active
Hsw Fine-Ject®	8300022136	FDA UDI	Class II	Active
Impression Jet	2930000240	FDA UDI	Class I	Active
Hsw Fine-Ject®	8300014163	FDA UDI	Class II	Active
Hsw Norm-Ject®	8300002328	FDA UDI	Class II	Active
Hsw Norm-Ject®	4010.200V0	FDA UDI	Class II	Active
Hsw Soft-Ject®	5010.290D0	FDA UDI	Class II	Active
Hsw Fine-Ject®	4710011025	FDA UDI	Class II	Active
Hsw Norm-Ject	8300014600	FDA UDI	Class I	Active
Hsw Fine-Ject®	4710009040	FDA UDI	Class II	Active
Rhinoscopes	8300060564	EUDAMED	Class IIa	Active
Surgical Trocar	8300055828	EUDAMEDFDA UDI	Class IIa	Active
Surgical Trocar	8300049697	EUDAMEDFDA UDI	Class IIa	Active
Arthroscopic Surgery Trocar	8300040040	EUDAMED	Class IIa	Active
Otoscopes	8300055081	EUDAMED	Class I	Active
Rhinoscopes	8300060543	EUDAMED	Class IIa	Active
Otoscopes	8300062478	EUDAMED	Class I	Active
Otoscopes	89550242	EUDAMED	Class I	Active
Rhinoscopes	8300067437	EUDAMED	Class IIa	Active
Rhinoscopes	89550263	EUDAMED	Class IIa	Active
Rhinoscopes	8300060546	EUDAMED	Class IIa	Active
Rhinoscopes	8300052777	EUDAMED	Class IIa	Active
Laryngoscope	8300003137	EUDAMED	Class I	Active
Arthroscopic Surgery Dilators	8300036860	EUDAMED	Class I	Active
Arthroscopic Surgery Dilators	89550603	EUDAMED	Class I	Active
Rhinoscopes	8300038573	EUDAMEDFDA UDI	Class IIa	Active
Arthroscopic Surgery Trocar	8300036858	EUDAMED	Class IIa	Active
Surgical Trocar	8300055823	EUDAMEDFDA UDI	Class IIa	Active
Arthroscopic Surgery Dilators	8300058741	EUDAMED	Class I	Active
Rhinoscopes	8300067427	EUDAMED	Class IIa	Active
Henke- Sass, Wolf Piston Syringe (norm-Jet)	K101547	FDA 510(k)	Class II	Active
Cystoscope 4.0mm autoclavable 0° WL 302mm; Hysteroscope 4.0mm autoclavable 0° WL 302mm; Cysto-Urethroscope Sheath 19 Fr.; Bridge for 17-25 Fr. Cysto-Urethroscope Sheath	K171336	FDA 510(k)	Class II	Active
HSW Resection Instruments	K173070	FDA 510(k)	Class II	Active
Elmed Pneumoperitoneum Needles	K943624	FDA 510(k)	Class II	Active
Hsw Gmbh Hysteroscopes & Accessories	K952186	FDA 510(k)	Class II	Active
Hsw Laparoscope And Accessories	K941967	FDA 510(k)	Class II	Active
Arthroscope	8300036855	EUDAMED	Class IIa	Active
Otoscopes	8300058412	EUDAMED	Class I	Active
Arthroscope	89550268	EUDAMED	Class IIa	Active
Arthroscopic Surgery Trocar	89550641	EUDAMED	Class I	Active
Otoscopes	8300059042	EUDAMED	Class I	Active
Surgical Trocar	8300055829	EUDAMEDFDA UDI	Class IIa	Active
Laparoscope	8300020555	EUDAMED	Class IIa	Active
Arthroscopic Surgery Trocar	89550621	EUDAMED	Class IIa	Active

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